[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lung-injuryali\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lung-injuryali":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,82,108,131],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100053330","outer-membrane-vesicle-and-ferroptosis-related-signatures-in-sepsis-associated-acute-lung-injury-caused-by-extra-pulmonary-hypervirulent-klebsiella-pneumoniae-100053330",false,"NCT07686887","Outer Membrane Vesicle and Ferroptosis-Related Signatures in Sepsis-Associated Acute Lung Injury Caused by Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae","Circulating Bacterial Outer Membrane Vesicle Signatures and Ferroptosis-Related Biomarkers in Sepsis-Associated Acute Lung Injury Among Patients With Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae Infection: A Prospective Observational Translational Cohort Study","OMV-FERRO-ALI","Inclusion Criteria:\n\n* Age 18-85 years .\n* Clinical suspicion of infection with acute organ dysfunction consistent with suspected sepsis at the time of enrollment, as determined by the treating clinical team.\n* Presumed extra-pulmonary source of infection at enrollment, including but not limited to hepatobiliary, urinary, intra-abdominal, skin and soft-tissue, vascular catheter-related, or primary bloodstream infection.\n* Blood cultures and\u002For clinically indicated source cultures obtained or ordered as part of routine clinical care.\n* Enrollment and first research blood collection completed within 6 hours after initiation of the clinical sepsis evaluation.\n* No evidence of acute lung injury at the index time point, according to the protocol-defined criteria.\n* Written informed consent obtained from the participant or legally authorized representative, unless an ethics-approved deferred-consent procedure is used.\n\nExclusion Criteria:\n\n* Suspected or confirmed primary pulmonary infection at enrollment, including community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, or aspiration pneumonia.\n\nAcute lung injury or acute respiratory distress syndrome present at the index time point.\n\n* Acute cardiogenic pulmonary edema, acute decompensated heart failure, or another condition that would preclude reliable adjudication of subsequent non-cardiogenic acute lung injury.\n* Recent inhalation injury, near-drowning, major thoracic trauma, or transfusion-related acute lung injury.\n* Previous enrollment in this study.\n* Inability to obtain informed consent from the participant or legally authorized representative when deferred-consent procedures are not permitted by the local ethics committee.","ALL","18 Years","85 Years",{"count":21,"type":22},120,"ESTIMATED","28 Days","OBSERVATIONAL","This prospective observational translational cohort study will investigate whether extra-pulmonary infection caused by hypervirulent Klebsiella pneumoniae (hvKP) is associated with an increased risk of sepsis-associated acute lung injury (SALI), compared with infection caused by classical Klebsiella pneumoniae (cKP). The study will further examine whether circulating bacterial outer membrane vesicle (OMV) signals and ferroptosis-related biomarker profiles are associated with subsequent SALI development.\n\nAdults with Sepsis-3 and microbiologically confirmed extra-pulmonary K. pneumoniae infection will be enrolled within 6 hours of sepsis recognition. Patients with acute lung injury at enrollment will be excluded from the primary cohort. Blood samples will be collected at enrollment, 24 hours, and 72 hours. Clinical isolates will undergo molecular characterization to classify infections as hvKP or cKP. The primary outcome will be new-onset SALI within 7 days after enrollment. A nested translational substudy will evaluate the effects of patient-isolate-derived OMVs on human pulmonary microvascular endothelial cells.\n\nThe study will not alter antimicrobial therapy, source control, respiratory support, fluid management, or any other aspect of routine clinical care.",[27,28,29,30],"Sepsis","Acute Lung Injury(ALI)","Klebsiella Pneumoniae Infection","Hypervirulent Klebsiella Pneumoniae Infection",[32,33,34,35,36,37,38,39],"Hypervirulent Klebsiella pneumoniae","Extra-pulmonary infection","Sepsis-associated acute lung injury","Bacterial outer membrane vesicles","Ferroptosis","Pulmonary microvascular endothelial cells","Lipid peroxidation","Endothelial barrier dysfunction","NOT_YET_RECRUITING","2026-07-09",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":22},"2026-07-06",{"date":48,"type":22},"2030-07-30",{"name":50,"class":51},"Southeast University, China","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100610259","recovery-of-physical-function-after-critical-illness-in-older-adults-100610259","NCT07225257","Recovery of Physical Function After Critical Illness In Older Adults","RETURN: Recovery of Physical Function After Critical Illness In Older Adults","RETURN","Inclusion Criteria:\n\n* adult patients (≥40 years of age)\n* patients who have survived an ICU admission of at least 72 hours\n* diagnosis of acute lung injury or sepsis are eligible.\n\nExclusion Criteria:\n\n* individuals who were not ambulatory prior to ICU admission,\n* not expected to survive at least 6 months,\n* have a new or pre-existing brain infarct, injury, or neurological condition with deficits preventing participation in physical testing,\n* have a pre-existing geriatric syndrome that were confound recovery trajectory",true,"99 Years",{"count":63,"type":22},150,"The proposed study is a prospective, observational study assessing the recovery of muscle and physical function in patients surviving critical illness (n =150) at hospital discharge (baseline) and repeated serially. Patients will be enrolled after life-saving modalities have been weaned near hospital discharge. Patients will participate in testing at baseline, 3-, 6-, 12-, and 24-months after hospital discharge. In a subset of patients (n = 18), muscle biopsies will be performed at baseline and then repeated once at either 12- or 24-months after hospital discharge.",[27,28],[67,68,69,70],"sepsis","acute respiratory failure","intensive care unit","Acquired muscle weakness","RECRUITING","2026-05-25",{"date":74,"type":44},"2026-05-28",{"date":76,"type":44},"2026-03-11",{"date":78,"type":22},"2031-12-31",{"name":80,"class":51},"University of Kentucky",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":60,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":81},"100581662","phase-2-this-study-is-assessing-the-safety-and-efficacy-of-immune-inhibition-as-a-treatment-to-prevent-primary-graft-dysfunction-100581662","NCT06853223","This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction","A Randomized Trial of CCR5 Inhibition as a Complement to Lung Transplant Induction Immunosuppression","MARAVIROC","Inclusion Criteria:\n\n1. Male or female ≥18 years of age at the time of lung transplant waitlisting.\n2. Listed for a bilateral lung transplantation.\n3. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n4. PGD risk score \\> 50% at the time of donor organ offer\n5. Planned induction with basiliximab, mycophenolatge, and prednisone and routine maintenance immunosuppression of tacrolimus, mycophenolate and prednisone.\n\nExclusion Criteria:\n\n1. Recipient scheduled to receive alternate induction regimen that is cell depleting such as anti-thymocyte globulin or alemtuzumab.\n2. Active chronic pulmonary infection in the recipient that are considered relative contraindications to lung transplantation such as Burkholderia or Mycobacterium abscessus.\n3. Recipients receiving HIV, HCV or HBV positive donor organs. Only documented infections are considered exclusion criteria. Recipients receiving increased risk organs will not be excluded.\n4. Recipient listed for concurrent heart or other solid organ transplantation.\n5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.",{"count":21,"type":22},"INTERVENTIONAL",[93],"PHASE2","Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1\u002F3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD.\n\nThe goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are:\n\nTo address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body.\n\nThis will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives.\n\nParticipants will:\n\nTake drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.",[96,97,28,98],"Primary Graft Dysfunction","Lung Transplantation","Natural Killer Cell Mediated Immunity","2026-01-15",{"date":101,"type":44},"2026-01-20",{"date":103,"type":44},"2025-12-07",{"date":105,"type":22},"2028-08-14",{"name":107,"class":51},"University of California, San Francisco",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":60,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":91,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":81},"100619252","phase-2-a-study-on-the-treatment-of-patients-with-acute-lung-injury-caused-by-sepsis-through-microbiota-transplantation-100619252","NCT07342205","A Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation","A Prospective, Single-center, Randomized, Double-blind Controlled Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Clear or suspected infection + SOFA score ≥ 2 points, and PaO₂\u002FFiO₂ ≤ 300 mmHg;\n* Capable of taking in nutrients (able to eat independently or receive enteral nutrition);\n* Voluntarily participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* Indications for exclusion from FMT (Fecal Microbiota Transplantation) include massive gastrointestinal bleeding, intestinal obstruction, organic intestinal disorders, and severe damage to intestinal mucosa;\n* Individuals with severe immune deficiencies, such as those with AIDS, leukemia, and those using immunosuppressive drugs;\n* Pregnant women and lactating women;\n* Those who cannot undergo nasal-intestinal catheterization or other transplantation methods;\n* Patients who cannot cooperate to complete the study; Other situations where the researchers determine that a patient is not suitable for participating in the clinical trial.",{"count":116,"type":22},60,[93,118],"PHASE3","Sepsis is a systemic inflammatory response syndrome triggered by infection, and it is a common critical illness in clinical practice, often leading to multiple organ dysfunction. Among these, acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are among the most severe complications. The mortality rate of sepsis-related lung injury is extremely high, reaching 30% - 50%. The existing treatment methods are unable to effectively reduce the high mortality rate of sepsis-related lung injury, and there are no specific treatment measures targeting lung injury itself. Dysbiosis of the intestinal flora plays an important role in the occurrence and development of sepsis-related lung injury. Fecal microbiota transplantation (FMT), as an effective means of regulating the intestinal flora, has shown certain therapeutic potential in some clinical studies. However, current research on FMT for treating sepsis-related lung injury is still in its infancy, and its mechanism is not yet fully clear. The clinical efficacy and safety also lack high-quality evidence support. Therefore, conducting this project's research will provide theoretical basis for targeted microecological treatment of sepsis-related lung injury; establishing a new strategy of combined microbiota transplantation technology for treating patients with sepsis ALI, and providing new ideas and methods for clinical treatment.",[121,28,122],"Acute Respiratory Distress Syndrome (ARDS)","Sepsis Related Acute Lung Injury\u002FAcute Respiratory Distress Syndrome","2026-01-07",{"date":99,"type":44},{"date":126,"type":44},"2025-12-10",{"date":128,"type":22},"2027-06",{"name":130,"class":51},"Shanghai University of Traditional Chinese Medicine",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":140,"conditions":141,"keywords":148,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":81},"100598351","digital-early-warning-system-for-acute-lung-injury-in-liver-surgery-100598351","NCT07070362","Digital Early Warning System for Acute Lung Injury in Liver Surgery","The Construction of a Digital Intelligence Early Warning System for the Whole Process of Acute Lung Injury in Liver Surgery Based on Cardiopulmonary Interaction Characteristics","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing major liver surgery (including two-segment or more hepatectomy, liver transplantation, etc.)\n* Voluntary participation with signed informed consent",{"count":139,"type":22},4000,"This study focuses on developing an explainable machine learning model based on cardiopulmonary interaction characteristics to achieve early prediction of acute lung injury (ALI) in patients undergoing major liver surgery. The research will establish a digital early-warning system for ALI to provide support for clinical diagnosis and treatment decisions, thereby reducing the incidence and fatality rate of ALI.",[28,142,143,144,145,146,147],"Liver Cirrhosis","ARDS, Human","MASLD","MASLD\u002FMASH (Metabolic Dysfunction-Associated Steatotic Liver Disease \u002F Metabolic Dysfunction-Associated Steatohepatitis)","NAFLD (Nonalcoholic Fatty Liver Disease)","Liver Cancer, Adult",[149,150,151,152,153],"Digital Intelligence","Acute Lung Injury","PPCs","Liver Surgery","Cardiopulmonary Interaction;","2025-07-08",{"date":156,"type":44},"2025-07-17",{"date":158,"type":44},"2024-11-01",{"date":160,"type":22},"2027-11-30",{"name":162,"class":51},"Beijing Tsinghua Chang Gung Hospital"]