[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"critical-illness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:critical-illness":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,247,0,25,[9,43,72,99,127,160,182,206,234,260,281,310,332,366,389,424,458,480,512,537,556,580,604,631,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100054105","phase-4-effects-of-melatonin-on-sleep-architecture-of-critically-ill-patients-in-the-icu-100054105",false,"NCT07691996","Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU","Inclusion Criteria:\n\n* 18 years or older, admitted to the ICU\n* Expected length of stay of at least 48 hours\n* Not mechanically ventilated\n* Able to take oral medications.\n* Hemodynamically stable as determined by the treating ICU physician\n* Able to provide informed consent or have consent provided by a legally -authorized representative.\n\nExclusion Criteria:\n\n* Mechanically ventilated\n* Currently using melatonin prior to ICU admission,\n* Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia.\n* Pregnant or lactating individuals\n* Those individuals with a comfort measures-only status","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.",[26,27,28,29,30],"Critical Illness","ICU","ICU Hospitalization","Melatonin","Sleep","NOT_YET_RECRUITING","2026-07-09",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":20},"2026-09-01",{"date":39,"type":20},"2028-01",{"name":41,"class":42},"Rutgers, The State University of New Jersey","OTHER",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100645274","metabolic-and-functional-study-of--t-cells-in-critically-ill-patients-100645274","NCT07680816","Metabolic and Functional Study of γδ T Cells in Critically Ill Patients","Subset-specific Metabolic Adaptation and Functional Remodeling of Gamma Delta T (γδ T) Cells in Critically Ill ICU Patients: A Single-center, Prospective, Observational Cohort Study.","Inclusion Criteria:\n\n1. Healthy Control Group (NHC):\n\n   * Age ≥ 18 years.\n   * No acute or chronic major diseases.\n   * Provide written informed consent.\n2. Non-septic Critical Illness Group (CI-NS):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the definition of critical illness.\n   * Excluded from sepsis according to the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n3. Septic Critical Illness Group (CI-Sep):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months.\n* Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids \\>1 mg\u002Fkg\u002Fday prednisone equivalent) before ICU admission or within 24 hours after ICU admission.\n* Use of immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies) within the past 6 weeks.\n* Expected ICU stay \\\u003C 24 hours or imminent risk of death (moribund state).\n* Pregnancy or breastfeeding.\n* Active major bleeding.\n* Inability to obtain informed consent.",true,"80 Years",{"count":53,"type":20},105,"OBSERVATIONAL","This prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδT cells in critically ill patients with and without sepsis. Emerging evidence indicates that γδT cells, as a bridge between innate and adaptive immunity, play a critical role in early anti-infection defense during sepsis. However, the functional status and underlying regulatory mechanisms of cytotoxic γδT cells in septic patients remain incompletely understood. Our preliminary single-cell transcriptomic analysis revealed that cytotoxic γδT cells from septic patients exhibit significant alterations in cytotoxicity-associated molecules (GZMB, PRF1, GNLY) and mitochondrial oxidative phosphorylation (OXPHOS) pathway genes, particularly COX6C, which correlates with cytotoxic effector molecule expression. This study aims to systematically characterize the proportion, cytotoxicity, and mitochondrial metabolic function of circulating cytotoxic γδT cells across three cohorts: healthy controls, critically ill non-septic patients, and critically ill septic patients. By integrating flow cytometry, mitochondrial function assays, and functional validation experiments, we seek to elucidate the role of COX6C-mediated mitochondrial metabolic abnormalities in cytotoxic γδT cell dysfunction, providing theoretical basis for understanding immune dysregulation in sepsis and identifying novel therapeutic targets.",[57,26,58,59,60,61,62],"Sepsis","Immunosuppression","MODS","Mitochondrial Diseases","Dysbiosis","γδ T Cells","2026-07-01",{"date":65,"type":35},"2026-07-02",{"date":67,"type":20},"2026-07-15",{"date":69,"type":20},"2027-07-15",{"name":71,"class":42},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100616550","real-time-algorithm-driven-ventilation-feedback-to-improve-lung-protective-ventilation-in-patients-with-ards-realvent-study-100616550","NCT07307066","Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)","REALVENT","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Receiving invasive mechanical ventilation via endotracheal intubation at the time of screening\n* Initiation of invasive mechanical ventilation within the past 24 hours\n* PaO₂\u002FFiO₂ ≤ 200 mmHg on PEEP ≥ 8 cmH₂O or, if arterial blood gas is unavailable: SpO₂\u002FFiO₂ ≤ 235 with SpO₂ ≤ 97%\n* Chest imaging (chest X-ray or CT) showing bilateral pulmonary infiltrates not fully explained by pleural effusions, lobar collapse, or pulmonary nodules\n* Respiratory failure not fully explained by cardiac failure or fluid overload\n* Expected to require invasive mechanical ventilation for ≥ 72 hours after enrollment\n\nExclusion Criteria:\n\n* Receipt of extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation at screening\n* Brain death or anticipated withdrawal of life-sustaining treatment within 72 hours\n* Pregnancy\n* Known neuromuscular disease affecting spontaneous respiratory effort\n* Prisoners or individuals unable to provide informed consent or surrogate consent\n* Simultaneous enrollment in another interventional ICU study\n* Lack of digital infrastructure for real-time ventilator waveform acquisition","75 Years",{"count":81,"type":20},208,[83],"NA","The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.",[86,87,88,26],"ARDS (Acute Respiratory Distress Syndrome)","VILI (Ventilator-induced Lung Injury)","Respiratory Failure","RECRUITING","2026-06-29",{"date":63,"type":35},{"date":93,"type":35},"2025-12-30",{"date":95,"type":20},"2027-02-28",{"name":97,"class":42},"Peking Union Medical College Hospital",1,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100644647","multimodal-sleep-promotion-in-surgical-icu-patients-100644647","NCT07672509","Multimodal Sleep Promotion in Surgical ICU Patients","Multimodal Sleep Promotion Intervention in Adult Postoperative Intensive Care Unit Patients: Two-Center Non-Randomized Controlled Pilot Study","MULTISLEEP","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients admitted to an adult intensive care unit after surgery.\n* Expected ICU stay of at least one night.\n* Patients with clinical stability and adequate pain control allowing participation in the intervention and completion of study assessments.\n* Patients able to understand and complete the questionnaires, either independently or with minimal assistance.\n* Patients without language barriers that prevent study participation.\n\nExclusion Criteria:\n\n* Patients with acute neurological impairment or moderate to severe cognitive dysfunction.\n* Patients receiving invasive mechanical ventilation with ongoing sedation.\n* Patients with a severe pre-existing sleep disorder requiring specific treatment not available in the ICU setting.\n* Patients unable to provide questionnaire responses due to communication limitations or clinical condition.\n* Patients with language barriers preventing participation in study procedures and completion of study assessments",{"count":108,"type":20},50,[83],"Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functional outcomes, and lower patient satisfaction.\n\nEnvironmental factors such as noise generated by alarms and medical equipment, continuous light exposure, frequent nursing interventions, pain, anxiety, and discomfort related to invasive devices have been identified as major contributors to sleep disruption in critically ill patients. Several non-pharmacological interventions, including earplugs, eye masks, environmental modifications, and nursing care bundles, have demonstrated potential benefits in improving sleep quality. However, most studies have focused on isolated interventions, and evidence regarding comprehensive multimodal approaches remains limited.\n\nThis two-center non-randomized controlled pilot study aims to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and reorganization of nursing care activities to minimize unnecessary sleep interruptions. Patients admitted to the intervention ICU will receive the multimodal sleep promotion program, while patients admitted to the control ICU will receive usual care.\n\nThe primary objective is to assess the effect of the intervention on patient-reported sleep quality. Secondary objectives include evaluating patient experience during ICU stay and exploring the relationship between sleep outcomes and selected demographic and clinical variables. The findings of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of multimodal sleep promotion strategies in adult ICU settings and may support the development of future larger-scale studies.",[112,26],"Sleep Wake Disorders",[114,115,116,117,118,119],"Sleep Quality","ICU Patients","Sleep Promotion","Sleep Hygiene","Patient Experience","Humanization of Care","2026-06-26",{"date":90,"type":35},{"date":63,"type":20},{"date":124,"type":20},"2026-11-30",{"name":126,"class":42},"Fundación de investigación HM",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":144,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":159},"100620841","myokine100-system-closed-loop-electrical-muscle-stimulation-to-mitigate-icu-acquired-weakness-in-medical-icu-patients-100620841","NCT07362862","MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients","Safety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness","ICUAW","Inclusion Criteria:\n\n* Admitted to ER or ICU within the previous 48 hours\n* APACHE II score ≥ 13\n* Meets the criteria for sepsis or severe sepsis\n* Baseline Clinical Frailty Scale (CFS) ≤ 4\n\nExclusion Criteria:\n\n* Anticipated transfer to an ICU not participating in this study\n* Expected length of ICU stay \\\u003C 48 hours\n* Myopathies (e.g. congenital)\n* Acquired myopathies with CK levels 5-times above the upper limit of normal\n* Unable to transfer from bed to chair at baseline\n* Moribund\n* Comfort care\n* New onset deep vein thrombosis within the previous 6-months\n* Malignancy in lower limb\n* Technical obstacles - fracture, burns, amputation\n* Open wound or skin abrasion at the garment application site\n* Pregnancy\n* Pacemaker and implantable cardioverter-defibrillator","85 Years",{"count":108,"type":20},[83],"The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.\n\nThe main questions this study aims to answer are:\n\n* Do participants develop medical problems when receiving electrical muscle stimulation in the ICU?\n* Is electrical muscle stimulation a practical way to help reduce muscle weakness in critically ill patients?\n\nResearchers will compare the control group (standard of care) to the intervention group (standard of care plus 60-minute sessions of electrical muscle stimulation daily during the ICU stay) to see if the device is safe and easy to use.\n\nParticipants will:\n\n* Receive either standard of care or standard of care plus electrical muscle stimulation of the thigh muscles\n* Have their muscle strength checked during the study\n* Complete a survey three months after ICU discharge to check on their recovery",[57,26,140,141,133,142,143],"ICU-acquired Muscle Weakness","ICU-acquired Weakness","Sarcopenia","Secondary Sarcopenia",[145,146,147,148,57,149,150],"Electrical muscle stimulation","Electrical Impedance Myography","Bioimpedance","Rehabilitation","Critical illness","ICU-acquired weakness",{"date":90,"type":35},{"date":153,"type":35},"2026-05-05",{"date":155,"type":20},"2027-08-31",{"name":157,"class":158},"Health Discovery Labs","INDUSTRY",3,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100644582","fmt-for-90-day-outcome-of-clinical-use-in-icu-sepsis-100644582","NCT07670299","FMT for 90-Day Outcome of Clinical Use in ICU Sepsis","Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial","FOCUS","Inclusion Criteria:\n\n* Age ≥ 18 years, any ethnicity, any gender.\n* Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.\n* Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.\n* Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.\n* Planned or recent abdominal surgery (within 14 days).\n* Current diagnosis of fulminant colitis or toxic megacolon.\n* Recent receipt of high-risk immunosuppressive or cytotoxic therapy, such as rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (≥20 mg\u002Fday of prednisone or equivalent) for more than 4 consecutive weeks.\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment.\n* Subjects for whom the validity of informed consent is questionable, including those with psychiatric disorders, intellectual disability, poor motivation, or other conditions that may limit their ability to provide informed consent.","70 Years",{"count":170,"type":20},60,[83],"Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a \"functional pulse\" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions.\n\nThis is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.",[57,26,174,61,175],"Gastrointestinal Dysfunction","Fecal Microbiota Transplantation","2026-06-25",{"date":120,"type":35},{"date":67,"type":20},{"date":180,"type":20},"2028-10-15",{"name":71,"class":42},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":98},"100638871","reframe-an-emotion-regulation-intervention-to-improve-psychological-outcomes-in-surrogate-decision-makers-of-the-critically-ill-100638871","NCT07630844","REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill","A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill","Patient Inclusion Criteria:\n\n* 1\\. Age ≥ 35 years\n* 2\\. Lacks decision-making capacity\n* 3\\. Not expected to be discharged from the ICU in 24 hours (including death)\n\nLegally Authorized Representative Inclusion Criteria (Primary Participant)\n\n* 1\\. Age ≥ 18 years\n* 2\\. Identified as LAR by ICU team\n* 3\\. Able to speak and understand English\n* 4\\. Able to visualize content on a tablet device\n\nPatient Exclusion Criteria:\n\n* 1\\. Age \\\u003C 35 years\n* 2\\. Possesses decision-making capacity\n* 3\\. Anticipated discharge from ICU within next 24 hours.\n\nLegally Authorized Representative Exclusion Criteria:\n\n* 1\\. Age \\\u003C 18 years\n* 2\\. Not recognized as LAR by ICU team\n* 3\\. Unable to speak and understand English\n* 4\\. Unable to visualize content on a tablet device",{"count":190,"type":20},387,[83],"Every year in the United States, millions of adults make crucial medical decisions for loved ones in the intensive care unit while facing extreme emotional stress. This project will assess REFRAME, a brief tablet-based program designed to help decision-makers manage their emotions in these situations. Results from this study may lead to the creation of a widely accessible tool that alleviates emotional suffering and enhances the quality of medical decision-making for families in crisis.",[26],[195,196,197],"Emotion Regulation","Psychological Distress","Surrogate Decision-Makers","2026-06-23",{"date":176,"type":35},{"date":201,"type":20},"2027-01-04",{"date":203,"type":20},"2031-04-04",{"name":205,"class":42},"Case Western Reserve University",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100530679","exhaled-breath-condensate-analysis-in-mechanically-ventilated-patients-100530679","NCT06189924","Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients","Proteomic Analysis of Exhaled Breath Condensate in Mechanically Ventilated Intensive Care Patients","Inclusion Criteria:\n\nIntensive care setting Mechanical ventilation Ventilator\u002Fventilator circuit technically suitable for sampling of exhaled breath condensate\n\nExclusion Criteria:\n\nMechanical ventilation challenging to the extent that the insertion of the sampling kit into the ventilator circuit would substantially increase the risk for respiratory deterioration",{"count":214,"type":20},200,"Mechanically ventilated intensive care patients will be sampled for a small amount of exhaled breath condensate from the ventilator circuit and for venous blood.\n\nProteomic analysis of the exhaled breath condensate will be performed using mass spectrometry and in the blood sample, corresponding changes in the DNA, RNA, proteins, and metabolites will be studied. Resulting profiles will be correlated with routinely monitored parameters in order to identify patterns corresponding to various pathologies in order to enable their early detection.",[217,26],"Acute Respiratory Failure",[219,220,221,222,223,224,225],"exhaled breath condensate","proteomics","genomics","mechanical ventilation","acute respiratory failure","lung injury","intensive care",{"date":176,"type":35},{"date":228,"type":35},"2026-03-01",{"date":230,"type":20},"2029-12-31",{"name":232,"class":42},"The Institute of Molecular and Translational Medicine, Czech Republic",2,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":242,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":245,"conditions":246,"keywords":250,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":159},"100480539","muscle-recovery-after-critical-illness-100480539","NCT05537298","Muscle Recovery After Critical Illness","Cellular and Physical Function Outcomes Leading to Failed Muscle Recovery After Critical Illness\u002FMuscle and Physical Functional Recovery After Acute Critical Illness","TRACER","Inclusion Criteria:\n\n* adult (\\>18 y\u002Fo)\n* admission for sepsis or acute respiratory failure with at least 72 hour stay in ICU\n\nExclusion Criteria:\n\n* patients who were not ambulatory prior to ICU admission\n* experienced \\>2 ICU admissions in the past year (chronic or recurrent critical illness due to the same or different reason\n* patients not expected to survive \\~6months after admission\n* acute or chronic neurologic condition\n* acute or chronic orthopedic condition preventing strength\u002Ffunctional testing\n* morbid obesity \\>50 kg\u002Fm2 due to distortion of muscle ultrasonography","MALE",{"count":244,"type":20},209,"The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness:\n\n1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments\n2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors\n3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission",[247,248,249,26],"ICU Acquired Weakness","Post Intensive Care Unit Syndrome","Muscle Weakness",[251,252],"skeletal muscle","physical function",{"date":120,"type":35},{"date":255,"type":35},"2022-10-18",{"date":257,"type":20},"2027-08-01",{"name":259,"class":42},"Esther Dupont-Versteegden",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":98},"100542369","improving-psychological-outcomes-for-acute-respiratory-failure-survivors-using-a-self-management-intervention-100542369","NCT06341972","Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention","SMARA","Inclusion Criteria:\n\n* ≥18 years old\n* English speaking and not aphasic\n* ARF with mechanical ventilation via endotracheal tube \\> 24 hours\n* Expected hospital stay of \\>7 days at time of eligibility\n* Alert (ie, Richmond Agitation Sedation Scale sedation score = -1, 0, or 1)\n* Not delirious (ie, negative Confusion Assessment Method -ICU score)\n* Presence of anxiety symptoms (Visual Analog Scale-Anxiety score ≥50)\\*\\*\n\nExclusion Criteria:\n\n* Pre-existing cognitive impairment (AD-8 score ≥2)\n* History of major psychiatric illness (i.e., psychotic disorder, bi-polar disorder, suicide attempt in past 24 months, pervasive developmental disorder, active substance use disorder)\n* Declines or incapable of informed consent\n* Anticipated discharge to hospice, primary focus on palliative care, or \\>90% probability of in-hospital death",{"count":170,"type":20},[83],"A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.\n\nThe goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is this intervention feasible and acceptable in ARF patients?\n* Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?\n\nParticipants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.",[88,271,26],"Anxiety","2026-06-18",{"date":274,"type":35},"2026-06-22",{"date":276,"type":35},"2024-05-31",{"date":278,"type":20},"2028-09-01",{"name":280,"class":42},"Johns Hopkins University",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100641399","inflammatory-and-genetic-predictors-of-cognitive-and-emotional-recovery-after-critical-illness-100641399","NCT07659431","Inflammatory and Genetic Predictors of Cognitive and Emotional Recovery After Critical Illness","Unraveling the Role of Cognitive Reserve, Inflammatory Phenotype and Genetic Vulnerability on Cognitive and Emotional Recovery After Critical Illness","CORE-ICU","Inclusion Criteria:\n\n* Adult patients (≥18 years)\n* Admitted to a medical-surgical ICU or cardiac ICU for causes of critical illness (e.g., acute pulmonary oedema, myocardial infarction, aortic dissection)\n* With or without the need for invasive mechanical ventilation\n* With an expected ICU stay of ≥48 hours\n* Resident in Catalonia or the Principality of Asturias\n* Who speak Catalan and\u002For Spanish\n* Who are able to provide informed consent personally or through an authorised representative (e.g., a family member)\n\nExclusion Criteria:\n\n* Non-authorisation by the patient and\u002For relatives for inclusion in the study\n* Patients admitted to a neurocritical ICU\n* History of severe neurological disease (including dementia or focal brain injury with functional and cognitive impairment) prior to ICU admission\n* History of severe psychiatric disorders (schizophrenia, bipolar disorder, major depressive disorder)\n* Intellectual disability (IQ \\\u003C80) or other neurodevelopmental disorders, such as autism spectrum disorder\n* Patients who develop secondary complications (e.g., infections, stroke, traumatic brain injury, or other non-transient acquired brain injury) after ICU discharge that may compromise the results of emotional and neuropsychological evaluations during the recovery phase\n* Moderate to severe cognitive impairment (Short-IQCODE \\>57) preventing independent participation in telemedicine or face-to-face follow-up\n* Readmission to the ICU within 12 months after ICU discharge\n* Language barrier (non-Spanish- and\u002For non-Catalan-speaking patients)\n* Patients with a life expectancy \\\u003C1 year or not eligible for active treatment measures",{"count":290,"type":20},114,"Survivors of critical illness frequently develop persistent cognitive and emotional impairments, known as post-intensive care syndrome (PICS), which substantially impact quality of life and long-term recovery. While prior research has mainly focused on identifying risk factors, the mechanisms underlying resilience to these sequelae remain poorly understood. Emerging evidence suggests that biological factors, including inflammatory responses and genetic vulnerability, together with cognitive reserve, may play a key role in shaping recovery trajectories.\n\nThe aim of this multicenter, prospective observational study is to investigate how cognitive reserve, inflammatory phenotype, and genetic profiles interact to influence cognitive and emotional recovery after critical illness. Adult patients will be recruited at Intensive Care Unit (ICU) admission across two centers in Spain. Clinical and sociodemographic data will be collected during the ICU stay, and biological samples obtained early after admission will undergo transcriptomic and genetic analyses. Cognitive and emotional outcomes will be assessed at hospital discharge and at 3 and 12 months post-discharge using standardised neuropsychological and telemedicine-based evaluations.\n\nBy integrating clinical, biological, and cognitive data, this study seeks to identify recovery phenotypes and resilience mechanisms in PICS. The results may contribute to improved risk stratification, inform personalized interventions, and support the development of future strategies aimed at reducing the long-term burden of critical illness.",[293,26],"Post-Intensive Care Syndrome (PICS)",[295,296,297,298,299,300,301,149],"Cognitive reserve","cognitive impairment","Inflammation biomarkers","APOE","ICU survivors","Emotional Outcomes","Post-intensive care syndrome (PICS)","2026-06-16",{"date":274,"type":35},{"date":305,"type":20},"2026-07",{"date":307,"type":20},"2028-06",{"name":309,"class":42},"Corporacion Parc Tauli",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":98},"100641424","swallowing-assessment-for-predicting-extubation-failure-in-critically-ill-patients-100641424","NCT07659275","Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients","Prospective Evaluation of the Prognostic Performance of an Orotracheal Tube-Adapted Swallowing Biomechanics Assessment for Predicting Extubation Failure in Critically Ill Patients","APEX","Inclusion Criteria:\n\n* Age ≥18 years.\n* Admission to an intensive care unit.\n* Invasive mechanical ventilation for ≥48 hours.\n* Successful completion of a spontaneous breathing trial according to local practice.\n* Ability to undergo bedside swallowing biomechanics assessment using the APEX score before extubation.\n* Written informed consent from the patient or legally authorized representative, when required by local regulations.\n\nExclusion Criteria:\n\n* Presence of a tracheostomy.\n* Decision to withhold or withdraw life-sustaining treatments.\n* Structural abnormalities of the upper airway or face precluding APEX assessment.\n* Conditions preventing assessment of swallowing biomechanics (e.g., maxillofacial trauma, recent head and neck surgery, or other conditions judged by the investigator to interfere with the evaluation).",{"count":319,"type":20},800,"Extubation failure, defined as the need for reintubation after planned removal of the endotracheal tube, occurs in up to 20% of critically ill patients and is associated with prolonged mechanical ventilation, longer intensive care unit (ICU) stay, and increased mortality. Current assessments of extubation readiness focus primarily on respiratory performance and do not routinely evaluate upper airway protective function.\n\nThe Airway Protection for Extubation (APEX) score is a bedside assessment tool based on swallowing biomechanics designed to evaluate airway protection before extubation. In a pilot prospective cohort study, the APEX score demonstrated promising performance for identifying patients at increased risk of extubation failure.\n\nThis prospective multicenter cohort study will be conducted across ICUs in Brazil to externally validate the APEX score in critically ill adults undergoing planned extubation. The study will evaluate the discrimination, calibration, and clinical utility of the APEX score for predicting extubation failure and will assess its performance across different patient populations and hospital settings.\n\nThe results of this study may support the incorporation of a simple bedside assessment of swallowing biomechanics into extubation readiness evaluation and contribute to more individualized decision-making regarding extubation in critically ill patients.",[322,323,26],"Extubation Failure","Mechanical Ventilation","2026-06-15",{"date":274,"type":35},{"date":327,"type":20},"2027-03-30",{"date":329,"type":20},"2030-10-30",{"name":331,"class":42},"Universidade Federal de Pernambuco",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":341,"conditions":342,"keywords":350,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100625308","mechanical-insufflation-exsufflation-in-critically-ill-patients-100625308","NCT07420946","Mechanical Insufflation-Exsufflation in Critically Ill Patients","Mechanical Insufflation-Exsufflation in Critically Ill Patients: An International DELphi Consensus (DELMI-E)","DELMI-E","Inclusion Criteria:\n\n* Healthcare professionals with documented clinical experience in critical care medicine, pulmonology, anesthesiology, respiratory therapy, or physiotherapy with involvement in airway clearance strategies.\n* Demonstrated experience or recognized expertise in the clinical use of MI-E, either in critically ill patients or in patients with complex respiratory conditions.\n* A minimum of 5 years of clinical experience in their respective field, or a proven academic or clinical contribution related to MI-E.\n* Willingness to participate in multiple Delphi rounds and to provide informed consent.\n* Ability to complete the questionnaires in English.\n\nExclusion Criteria:\n\n* Lack of direct clinical or academic experience related to MI-E or airway clearance techniques.\n* Inability or unwillingness to provide informed consent.\n* Failure to complete the first Delphi round after formal invitation and consent.\n* Withdrawal of consent at any stage of the Delphi process.",{"count":19,"type":20},"Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.",[343,344,345,346,347,26,348,349],"Airway Clearance","Mechanical Insufflation-exsufflation","Mechanical Insufflation-exsufflation Session ( With Cough Assist)","Delphi Study","Consensus","Critical Care","Critical Care, Intensive Care",[351,352,353,347,354,355,356],"mechanical insufflation-exsufflation","Airway clearance","Delphi study","Cough assist","MI-E","critical care",{"date":358,"type":35},"2026-06-17",{"date":360,"type":35},"2026-06-10",{"date":362,"type":20},"2026-12-01",{"name":364,"class":42},"Medipol University",4,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":16,"minAge":373,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":98},"100516552","evaluating-the-unmet-needs-of-older-adults-to-promote-functional-recovery-after-a-critical-illness-100516552","NCT06006000","Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness","LANTERN","Inclusion Criteria:\n\nPARTICIPANTS\n\n* Age ≥ 65 years\n* Survived an ICU admission of ≥2 days\n\nCAREGIVERS\n\n* Age ≥ 18 years\n* Identified as caregiver of LANTERN participant who is an informal (unpaid) caregiver.\n\nExclusion Criteria:\n\nPARTICIPANTS\n\n* Advance directive of comfort measures only (CMO) or a transition to hospice\n* Planned discharge to a location other than home or Short-Term Rehab\n* Tracheostomy with ventilator dependence\n* Severe acute or prior neurologic injury (such as anoxic brain injury or acute, massive stroke)\n* Advanced dementia\n* ICU admission for monitoring only (e.g., antibiotic desensitization)\n* Primary language other than English.\n* Homelessness\n* Active drug or alcohol use disorder.\n\nCAREGIVERS\n\n* Primary language other than English\n* Is a paid caregiver\n* Unwilling to complete a qualitative interview","65 Years",{"count":375,"type":20},350,"This is a prospective longitudinal study that will evaluate the unmet needs of older adults (65 and older) who return home (either directly or after short-term rehab) after an ICU hospitalization, evaluate the association of these unmet needs with clinically relevant outcomes, and assess barriers and facilitators to addressing these unmet needs. The proposed research will inform the development and evaluation of a subsequent intervention to improve functional outcomes among older ICU survivors, in alignment with the NIH's mission to reduce disability.",[26,378],"Illness, Critical",[380,381],"Geriatrics","Older Adults",{"date":358,"type":35},{"date":384,"type":35},"2024-01-25",{"date":386,"type":20},"2028-10",{"name":388,"class":42},"Yale University",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":21,"phases":398,"briefSummary":399,"conditions":400,"keywords":406,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"locationsCount":98},"100641181","compare-vent-feasibility-pilot-study-100641181","NCT07656259","COMPARE-VENT Feasibility Pilot Study","COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease","Inclusion Criteria:\n\nEligible adults ≥ 18 years of age admitted to the cardiac ICU with need for invasive mechanical ventilation of expected duration \\>12 hours.\n\nPre-Specified Subgroups for exploratory outcomes:\n\n1. SCAI Stages C-E Cardiogenic Shock\n2. Mechanical circulatory support use, including intra-aortic balloon pumps and microaxial flow pumps, including Impella CP, RP Impella Flex, and Impella 5.5 devices\n3. Heart failure with reduced ejection fraction: LVEF \\\u003C40% or;\n4. Moderate to severe RV systolic dysfunction or;\n5. Moderate to severe Pulmonary hypertension, as defined by ACC\u002FAHA\u002FESC guidelines\n\nExclusion Criteria:\n\n1. Expected duration of intubation \\\u003C12 hours.\n2. Severe COPD, bronchopleural fistulas, or severe ARDS (Berlin criteria P\u002FF \\\u003C100, in the absence of pulmonary edema)\n3. Home ventilator or chronic tracheostomy.\n4. Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation",{"count":397,"type":20},75,[83],"Cardiac disease complicated by respiratory insufficiency comprises the most frequent indication for cardiac intensive care unit (CICU) admission, with nearly one-third patients requiring advanced respiratory support and over 20% patients requiring invasive mechanical ventilation (IMV). IMV among patients with impaired cardiovascular reserve is further compounded by the adverse impact of positive pressure ventilation (PPV) and systemic sedation on intracardiac hemodynamics, pulmonary vascular mechanics and consequently end-organ perfusion. Despite widespread use, evidence guiding optimal ventilatory practices and mode selection in cardiovascular intensive care unit patients remains limited. Pressure-controlled and volume-controlled ventilation may differ in their effects on patient-ventilator synchrony, sedation requirements, and hemodynamic impact, but comparative data among patients with critical cardiac disease remains inconclusive. This pilot study will evaluate the feasibility of implementing a pragmatic cluster-randomized crossover trial comparing ventilatory modes in a contemporary cardiovascular intensive care unit.",[401,402,403,26,323,404,405],"Respiration Failure","Cardio Vascular Disease","Cardiogenic Pulmonary Oedema","Cardiogenic Shock","Cardiopulmonary",[407,408,409,410,411,149,412,413,414,415,416],"Cardiovascular disease","Cardiac arrest","Cardiogenic shock","Respiratory failure","Cardiopulmonary interactions","Intensive care unit","Critical care therapies","Outcomes","Mechanical ventilation","Positive pressure ventilation","2026-06-14",{"date":272,"type":35},{"date":63,"type":20},{"date":421,"type":20},"2027-06-30",{"name":423,"class":42},"Mayo Clinic",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":432,"targetDuration":4,"studyType":21,"phases":434,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":98},"100641107","effects-of-anisodamine-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641107","NCT07657702","Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","ANISO-MICRO","Inclusion Criteria:\n\n* Age 18-85 years.\n* Diagnosis of septic shock according to Sepsis-3 criteria, defined as suspected or documented infection with vasopressor requirement to maintain mean arterial pressure ≥65 mmHg and serum lactate \\>2 mmol\u002FL after adequate fluid resuscitation.\n* Enrollment within 24 hours after diagnosis of septic shock or within 24 hours after ICU admission for septic shock.\n* Receiving invasive mechanical ventilation at the time of enrollment.\n* PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before anisodamine initiation.\n* Continuous norepinephrine infusion at enrollment.\n* Adequate initial fluid resuscitation and hemodynamic optimization as judged by the treating physician, with volume status assessed by dynamic indices, echocardiography, or PiCCO-derived variables.\n* Ability to obtain sublingual microcirculatory images of acceptable quality at baseline.\n* Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Shock mainly caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or withdrawal of life-sustaining treatment within 24 hours.\n* Known contraindications to anisodamine or anticholinergic therapy, including glaucoma, acute phase of intracranial hemorrhage, elevated intracranial pressure, untreated bowel obstruction, or prostatic enlargement without urinary catheterization.\n* Known allergy or hypersensitivity to anisodamine or any component of the study drug.\n* Severe or uncontrolled arrhythmia before enrollment, including sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, uncontrolled supraventricular tachycardia, or atrial fibrillation\u002Fflutter with uncontrolled ventricular response.\n* Acute coronary syndrome, clinically significant myocardial ischemia, or cardiac arrest before enrollment during the current ICU stay.\n* Severe cardiac dysfunction judged unsuitable for anisodamine by the treating physician, including severe ventricular dysfunction, cardiogenic shock, or need for high-dose inotropic support.\n* Conditions interfering with sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n* Immunocompromised status or agranulocytosis, including long-term immunosuppressive therapy, chemotherapy-associated severe neutropenia, or other severe immune suppression judged by the investigator.\n* Pregnancy, planned pregnancy, or lactation.\n* Participation in another interventional clinical trial that may affect study outcomes or safety.\n* Inability to obtain informed consent.",{"count":433,"type":20},20,[83],"This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous anisodamine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock.\n\nEligible patients will have septic shock according to Sepsis-3 criteria, will require norepinephrine support after adequate fluid resuscitation, and will be receiving invasive mechanical ventilation and PiCCO-based hemodynamic monitoring. After baseline assessment, participants will receive intravenous anisodamine according to the study protocol. Anisodamine will be administered as a loading dose of 0.5 mg\u002Fkg within 3 minutes, with a minimum dose of 20 mg and a maximum dose of 40 mg, followed by continuous infusion at 0.02-0.1 mg\u002Fkg\u002Fhour, with a maximum total daily dose of 200 mg.\n\nSublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of anisodamine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived variables, and safety outcomes will also be collected.\n\nThe primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after anisodamine administration and to provide preliminary data for future controlled studies.",[437,57,26],"Septic Shock",[439,440,441,442,443,444,445,446,447,448,449,222,450],"anisodamine","anisodamine hydrobromide","septic shock","sublingual microcirculation","microvascular flow index","vascular waterfall","critical closing pressure","mean systemic filling pressure","Pcc","Pmsf","PiCCO","arrhythmia",{"date":272,"type":35},{"date":453,"type":20},"2026-08-01",{"date":455,"type":20},"2027-12-30",{"name":457,"class":42},"First Affiliated Hospital of Wannan Medical College",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":466,"targetDuration":4,"studyType":21,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":478,"leadSponsor":479,"locationsCount":233},"100641303","effects-of-dexmedetomidine-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641303","NCT07657715","Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","DEX-MICRO","Inclusion Criteria:\n\n* Age 18-85 years.\n* Diagnosis of septic shock according to Sepsis-3 criteria, defined as suspected or documented infection with vasopressor requirement to maintain mean arterial pressure ≥65 mmHg and serum lactate \\>2 mmol\u002FL after adequate fluid resuscitation.\n* Enrollment within 24 hours after diagnosis of septic shock in the ICU.\n* Receiving invasive mechanical ventilation.\n* Receiving continuous intravenous sedative and\u002For analgesic therapy other than dexmedetomidine before enrollment, with a clinical decision to add dexmedetomidine for sedation management.\n* Continuous norepinephrine infusion at enrollment.\n* PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation.\n* Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Shock primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or withdrawal of life-sustaining treatment within 24 hours.\n* Known allergy or hypersensitivity to dexmedetomidine.\n* Severe bradycardia or clinically significant conduction abnormality before enrollment, including heart rate \\\u003C50 beats\u002Fmin, second-degree or third-degree atrioventricular block, sick sinus syndrome, or other conduction abnormality without a functioning pacemaker.\n* Severe uncontrolled arrhythmia, acute coronary syndrome, or clinically significant myocardial ischemia before enrollment.\n* Severe hemodynamic instability judged unsuitable for dexmedetomidine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.\n* Severe hepatic dysfunction judged by the investigator to substantially increase the risk of dexmedetomidine accumulation or adverse effects.\n* Conditions interfering with sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n* Pregnancy or lactation.\n* Participation in another interventional clinical trial that may affect study outcomes or safety.",{"count":433,"type":20},[83],"This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous dexmedetomidine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock.\n\nEligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, receive invasive mechanical ventilation, and have PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation. After baseline assessment, participants will receive intravenous dexmedetomidine according to the study protocol. Dexmedetomidine will be administered as a continuous intravenous infusion at 0.2-0.7 µg\u002Fkg\u002Fhour without a loading dose. The infusion rate may be adjusted according to the target sedation level, hemodynamic status, and adverse effects.\n\nSublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of dexmedetomidine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived, sedation-related, and safety outcomes will also be collected.\n\nThe primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after dexmedetomidine administration and to provide preliminary data for future controlled studies.",[437,57,26],[471,441,442,443,444,445,446,447,448,449,222,472,473,474,475],"dexmedetomidine","sedation","bradycardia","hypotension","norepinephrine",{"date":272,"type":35},{"date":453,"type":20},{"date":455,"type":20},{"name":457,"class":42},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":489,"conditions":490,"keywords":495,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":511},"100642154","volume-removal-intolerance-during-net-ultrafiltration-in-acute-kidney-injury-patients-100642154","NCT07643597","Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients","VINKO","Inclusion Criteria:\n\n* Age ≥18 years\n* Admission to an Intensive Care Unit\n* Acute kidney injury according to KDIGO criteria\n* Prescription of continuous renal replacement therapy (CRRT) with net ultrafiltration\n* Clinical stability considered sufficient to initiate net ultrafiltration according to the treating clinical team\n\nExclusion Criteria:\n\n* Chronic kidney replacement therapy prior to ICU admission\n* Pregnancy\n* Limitation of therapeutic effort or goals-of-care decisions at admission or during the observation period\n* Inability to perform hemodynamic or perfusion assessment\n* Extracorporeal membrane oxygenation (ECMO)\n* Refusal to participate in the study",{"count":488,"type":20},128,"Acute kidney injury (AKI) is common in critically ill patients and is frequently associated with fluid overload, which can worsen clinical outcomes. Continuous renal replacement therapy (CRRT) allows fluid removal through net ultrafiltration (UFNET), but some patients develop hemodynamic instability or signs of poor tissue perfusion during this process.\n\nThe purpose of this prospective observational study is to evaluate tolerance to net ultrafiltration in critically ill patients with AKI receiving CRRT. The study will assess clinical, hemodynamic, ultrasound, perfusion, and biochemical parameters before and during fluid removal to identify factors associated with ultrafiltration intolerance.\n\nThe investigators hypothesize that alterations in hemodynamic, perfusion, and congestion-related parameters can identify patients at increased risk of ultrafiltration intolerance before the development of overt hypotension. The results may help improve individualized fluid removal strategies and optimize the safety of CRRT in critically ill patients.",[491,492,493,26,494],"Acute Kidney Injury","Fluid Overload","Fluid Overload in Dialysis Patients","Renal Replacement Therapy for Acute Kidney Injury in ICU",[496,497,498,499,500,492,501,502],"Net Ultrafiltration","Continuous Renal Replacement Therapy","Fluid Removal","Ultrafiltration Intolerance","Tissue Hypoperfusion","VExUS","Point-of-Care Ultrasound","2026-06-13",{"date":302,"type":35},{"date":506,"type":20},"2026-07-06",{"date":508,"type":20},"2027-12-01",{"name":510,"class":42},"Hospital Las Higueras",10,{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":519,"enrollmentInfo":520,"targetDuration":4,"studyType":21,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":98},"100560314","phase-4-efficacy-and-safety-of-remimazolam-besylate-for-sedation-in-post-non-cardiac-surgery-patients-requiring-mechanical-ventilation-100560314","NCT06575530","Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation","Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged between 18 and 64 years\n* Scheduled to undergo elective non-cardiac surgery\n* Planned for general anesthesia\n* With or without combined regional nerve blockade\n* Admitted to the ICU with endotracheal intubation post-surgery\n* With an anticipated duration of postoperative mechanical ventilation greater than 24 hours\n* Clinically requiring light sedation( target RASS score 0 to -2)\n\nExclusion Criteria:\n\n* Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases\n* Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease\n* Inability to communicate preoperatively due to coma, severe dementia, or language barriers\n* Preoperative .cardiac insufficiency or severe cardiac arrhythmias\n* Severe hepatic impariment( Child-Pugh class C)\n* Severe renal impariment\n* Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam\n* Pregnancy or lactation\n* Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment\n* Any other conditions deemed by the investigators to render the patient unsuitable for study participation\n* Refusal to provide written informed consent","64 Years",{"count":521,"type":20},306,[23],"A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.",[525,526,527,26,528,529],"Effect of Drug","Adverse Drug Event","Mechanical Ventilation Complication","Surgery","Sedation",{"date":302,"type":35},{"date":532,"type":35},"2025-01-20",{"date":534,"type":20},"2026-06-30",{"name":536,"class":42},"Beijing Shijitan Hospital, Capital Medical University",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":373,"enrollmentInfo":544,"targetDuration":4,"studyType":21,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":552,"leadSponsor":554,"locationsCount":98},"100642749","phase-4-fluorescent-probe-for-assessment-of-renal-elimination-100642749","NCT07643467","Fluorescent Probe for Assessment of Renal Elimination","FLARE","Inclusion Criteria:\n\n* 18-65 years old\n* critically ill or acutely ill hospitalized patients admitted to the intensive care unit\n* Stable\u002Fnormal renal function\n\nExclusion Criteria:\n\n* Prisoners\n* Pregnant women\n* Laboratory evidence of unstable kidney function (KDIGO AKI stage 1-3--This includes subjects with Scr \\> 1.5x baseline)",{"count":214,"type":20},[23],"Accurate measures of kidney function is important for precision dosing of many medications. The current methods of determining kidney function largely hinge on the use of equations that use common laboratory values such as serum creatinine \\& static variables like age \\& weight. These are helpful for trending over time, but often are inaccurate during times of medical illness. Other more accurate methods of measuring kidney function include urine collection, although this is not commonly used because of various reasons that make the collection inconvenient or unreliable. The new transdermal glomerular filtration (tGFR) device permits accurate, real-time evaluation of kidney function. This novel method has not been rigorously compared with urine collection \\& other methods of determining kidney function in hospitalized patients. The goal of the study is to compare tGFR with other accepted methods of determining kidney function.",[548,26],"Augmented Renal Clearance","2026-06-12",{"date":302,"type":35},{"date":305,"type":20},{"date":553,"type":20},"2028-06-30",{"name":555,"class":42},"Aaron Cook",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":21,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":159},"100642234","self-directed-mobile-mindfulness-to-address-icu-survivors-psychological-distress-100642234","NCT07634419","Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress","Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress: Lift RCT (Lift 3)","Lift 3","Inclusion Criteria:\n\nInclusion criteria present during hospitalization\n\n1. Adult (age ≥18)\n2. Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met\n3. Serious acute cardiorespiratory condition, defined as ≥1 of the following:\n\n   * mechanical ventilation via endotracheal tube for ≥4 hours\n   * non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure\n   * new use of supplemental oxygen ≥6 liters per minute (or increase in baseline continuous oxygen)\n   * use of vasopressors for shock of any etiology\n   * use of inotropes for shock of any etiology\n   * use of pulmonary vasodilators\n   * use of aortic balloon pump or cardiac assist device for cardiogenic shock\n   * use of diuretic intravenous drip\n   * evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)\n   * urgent cardiac catheterization\n4. Cognitive status intact\n\n   o No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart\n5. Absence of severe and\u002For persistent mental illness\n\n   o Treatment for severe and\u002For persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \\[as per medical record\\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission\n6. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)\n\nInclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital):\n\n1\\. Elevated baseline psychological distress symptoms, defined as a PHQ-9 score ≥5\n\nExclusion Criteria:\n\nExclusion criteria present in the hospital:\n\n1\\. Discharged to a location other than a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)\n\nExclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital):\n\n1. Severe psychological distress as assessed by endorsement of active suicidality (see Protection of Human Subjects document for study team management of this finding)\n2. Failure to randomize within 1 month after discharge from the hospital to home\n3. Failure to login to study app and access content within 2 weeks after randomization",{"count":565,"type":20},450,[83],"Serious acute heart and lung illnesses like heart failure, severe COVID, and sepsis often leave survivors struggling not only physically, but also with lasting depression, anxiety, and stress. These problems that are hard to treat because access to mental health care is often limited. To help address this, the researchers created Lift, a fully automated mindfulness program designed with patient input and delivered through a mobile app. The investigators now plan a large, multi-site study to test whether Lift improves mental health and quality of life over six months compared to a critical illness education program called Enlighten Recovery. Overall the goal is to make an easy-to-use, widely accessible program available to people across the U.S., including those who speak Spanish.",[26,569,57,570,571,572],"Heart Failure","Ards","Pneumonia","Trauma Injury",{"date":302,"type":35},{"date":575,"type":20},"2026-06-01",{"date":577,"type":20},"2031-05-31",{"name":579,"class":42},"Duke University",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":98},"100641384","hemodynamic-effects-of-norepinephrine-reduction-on-critical-closing-pressure-in-distributive-shock-100641384","NCT07653659","Hemodynamic Effects of Norepinephrine Reduction on Critical Closing Pressure in Distributive Shock","Changes in Critical Closing Pressure and Derived Hemodynamic Parameters Following Norepinephrine Dose Reduction in Distributive Shock Patients: a Prospective Observational Study","Inclusion Criteria:\n\n1. Adult distributive shock patients aged ≥18 years;\n2. Receiving norepinephrine infusion with MAP in the 75-85 mmHg range;\n3. PiCCO catheter in situ;\n4. Under mechanical ventilation;\n5. Clinically indicated norepinephrine dose reduction per attending physician judgment.\n\nExclusion Criteria:\n\n1. Significant cardiac arrhythmia affecting CO measurement reliability;\n2. Contraindication to airway plateau pressure maneuver;\n3. Active titration of other vasoactive agents within 30 minutes prior to measurement;\n4. Hemodynamic instability making it impossible to reduce norepinephrine dose.",{"count":19,"type":20},"This study prospectively observes changes in critical closing pressure (Pcc) and derived hemodynamic parameters in mechanically ventilated distributive shock patients when clinically indicated norepinephrine dose reduction is performed by the attending physician. Pcc is measured before and 30 minutes after dose reduction using a stepwise inspiratory hold maneuver via PiCCO monitoring.",[590,591,26],"Distributive Shock","Hemodynamic Assessment",[593,594,595,596,597],"Critical closing pressure","Tissue perfusion pressure","Vascular waterfall","Norepinephrine dose","Distributive shock",{"date":358,"type":35},{"date":600,"type":35},"2025-09-01",{"date":602,"type":20},"2027-09-01",{"name":97,"class":42},{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":21,"phases":614,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":98},"100620941","phase-2-exogenous-ketone-supplementation-in-icu-delirium-100620941","NCT07364162","Exogenous Ketone Supplementation in ICU Delirium","Exogenous Ketone Ester Supplementation in ICU Delirium (KETONES ICU)","KETONES-ICU","Inclusion criteria:\n\n1. Adult patients (≥18 years old) admitted to the medical intensive care unit.\n2. Current ICU admission with anticipated ICU stay ≥24 hours.\n3. Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of enrollment.\n4. Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment.\n\nExclusion criteria:\n\n1. Severe metabolic acidosis at screening: blood gas pH \\\u003C7.20 or bicarbonate \\\u003C 8 mmol\u002FL.\n2. Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state.\n3. Hypoglycemia as an ICU admission diagnosis or glucose \\\u003C60 mg\u002FdL.\n4. Patients with a history of type 1 diabetes mellitus.\n5. Hemoglobin \\\u003C7.0.\n6. Fulminant hepatic failure or AST\u002FALT \\> 5× ULN or total bilirubin \\> 3 mg\u002FdL.\n7. Refractory shock (defined as norepinephrine dose ≥20 µg\u002Fmin or use of a second vasopressor agent).\n8. Pregnancy (positive urine\u002Fserum hCG at screening or known pregnancy).\n9. Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing.\n10. SGLT2 inhibitor use within the prior 7 days.\n11. ADH\u002FALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned.\n12. Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE \\>4.5, measured using a patient's qualified surrogate. This exclusion also pertains to mental illnesses requiring long-term institutionalization, acquired or congenital intellectual disability, severe neuromuscular disorders, Parkinson's disease, and Huntington's disease. It also excludes patients with severe deficits due to structural brain diseases such as stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema.\n13. Benzodiazepine dependency or alcohol dependency based on the medical team's decision to institute a specific treatment plan involving benzodiazepines or barbiturates (either as continuous infusions or intermittent intravenous boluses) for this dependency.\n14. Active seizures during this ICU admission being treated with intravenous benzodiazepines.\n15. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family\u002Fmedical team (e.g., likely to withdraw life support measures within 24 hours of screening).\n16. Admission to ICU only for post-operative monitoring or frequent neurologic assessments.\n17. Incarcerated status.\n18. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal.\n19. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and\u002For surrogate refusal.\n20. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available.\n21. Current enrollment in a study that does not allow co-enrollment.",{"count":613,"type":20},40,[615],"PHASE2","Delirium is a common syndrome in intensive care unit (ICU) patients. Those experiencing delirium may suddenly feel confused, have trouble thinking clearly, struggle to pay attention, or see and hear things that are not real. Delirium is associated with worse long-term outcomes such as cognitive impairment, depression, and PTSD (post-traumatic stress disorder). This study examines whether an investigational medical-grade ketone supplement drink (ketone monoester \\[brand name: Ultrapure Ketone Monoester\\]) is safe and feasible to use in ICU patients, and to look for signals that it might reduce delirium or shorten its duration compared to a volume-, taste-, and calorie-matched placebo.",[618,26],"ICU Delirium",[27,620,621,149,622],"Intensive Care Unit","Critical care","Ketones","2026-06-11",{"date":324,"type":35},{"date":626,"type":35},"2026-06-09",{"date":628,"type":20},"2027-12-31",{"name":630,"class":42},"Vanderbilt University Medical Center",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":637,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":640,"conditions":641,"keywords":644,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":233},"100530991","icu-combined-assessment-of-cardio-respiratory-exercise-100530991","NCT06193980","ICU Combined Assessment of Cardio-Respiratory Exercise","Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness","ICU-CARE","Inclusion Criteria:\n\n* Patients who have received mechanical ventilation for at least 7 days in the intensive care unit (ICU) and have subsequently been discharged from hospital.\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Trajectory of health expected to be significantly limited in the upcoming 12 months\n* those who self-report that they cannot climb at least one flight of stairs due to limited exercise capacity\n* have significant orthopedic or musculoskeletal impairment affecting mobility\n* have a medical history of neuromuscular disease\n* ongoing respiratory limitations (i.e., supplemental oxygen)\n* significant heart disease (i.e. ejection fraction less than 30%, unstable ischemic heart disease, severe valvular heart disease)\n* a body mass index (BMI) of ≥ 40 kg\u002Fm2 (impacting NIRS signal due to adipose tissue thickness)\n* if participant's primary residence is a significant distance from the participating study site",{"count":108,"type":20},"This study aims to investigate how sepsis and critical illness can impair the cardiovascular system and microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness\u002Fdysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.",[247,57,642,26,643],"Shock","Microcirculation",[645,646,643,251,647,648,649,650],"ICU Survivors","Oxygen Delivery","Exercise","near-infrared spectroscopy","cardiopulmonary exercise test","cardiovascular physiology",{"date":324,"type":35},{"date":653,"type":35},"2023-12-15",{"date":655,"type":20},"2029-12",{"name":657,"class":42},"University of Manitoba",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":667,"conditions":668,"keywords":671,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":686,"leadSponsor":687,"locationsCount":98},"100642436","intravenous-fluid-practices-in-turkish-intensive-care-units-tr-fluid-100642436","NCT07649694","Intravenous Fluid Practices in Turkish Intensive Care Units (TR-FLUID)","TR-FLUID: Evaluation of Intravenous Fluid Administration Practices in Turkish Intensive Care Units: A Multicenter, Prospective, Point-Prevalence Observational Study","Inclusion Criteria:\n\n* Aged 18 years or older\n* Present in a participating intensive care unit at the index time (08:00 local time on the center's selected study day); no minimum or maximum ICU length of stay is required\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Refusal of study participation by the patient or their legal representative",{"count":666,"type":20},400,"Intravenous (IV) fluids-fluids given directly into a vein-are among the most common treatments used in intensive care units (ICUs). They are given for several reasons, such as supporting blood pressure, providing daily water and salts, replacing losses, or diluting medications. However, the type of fluid, the amount given, and the salt (sodium and chloride) load can vary widely between hospitals and doctors. In Turkey, there is currently no up-to-date, multicenter information describing how IV fluids are used in adult ICUs in everyday practice.\n\nThis study, called TR-FLUID, aims to describe IV fluid use in adult ICUs across Turkey. It is an observational study, meaning the researchers only observe and record care that is already being provided. No extra tests, medications, or procedures are added, and the study does not change how patients are treated in any way.\n\nOn a single pre-selected study day at each participating ICU, the research team will identify all adult patients (18 years and older) who are in the ICU at 8:00 a.m. For each patient, the team will record the IV fluids given over the following 24 hours-including the fluid type, the volume, the reason it was given, and the resulting sodium and chloride load-together with the patient's fluid balance. All information is taken from the patient's existing medical records.\n\nThe main goal is to determine what proportion of patients receive fluids for resuscitation and which fluid types are used. The study will also describe the total fluid, sodium, and chloride given by indication; the 24-hour fluid balance; and how fluid use relates to short-term events such as the need for blood-pressure-supporting medications, new kidney injury, and ICU and hospital survival. These relationships will be explored to generate hypotheses and are not intended to prove cause and effect.\n\nThe findings will provide a national picture of current fluid practice in Turkish ICUs, help identify where practice differs from guidelines, and serve as a foundation for future quality-improvement and research efforts.",[26,669,670],"Fluid Therapy","Practices",[672,673,674,675,676,677,678,679,680,681,682,683,621],"TR-FLUID","Intravenous fluid therapy","Fluid resuscitation","Resuscitation fluid","Balanced crystalloids","Normal saline","Albumin","Fluid creep","Maintenance fluids","Fluid balance","Chloride load","Fluid stewardship",{"date":302,"type":35},{"date":37,"type":20},{"date":602,"type":20},{"name":688,"class":42},"Ondokuz Mayıs University"]