[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-abdominal-surgeries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-abdominal-surgeries":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,76,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100637848","evaluate-the-performance-of-the-dexcom-g7-continuous-glucose-monitoring-cgm-system-in-critically-ill-patients-undergoing-major-abdominal-surgery-and-solid-organ-transplantation-which-require-blood-glucose-monitoring-for-intensive-insulin-therapy-100637848",false,"NCT07611721","Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.","Determining the Reliability and Accuracy of the Dexcom G7 Continuous Glucose Monitoring System in the ICU","DREAM-ICU","Inclusion Criteria:\n\n* Age 18 years or over\n* Intensive care unit admission\n* Requiring blood glucose monitoring for insulin therapy\n\nExclusion Criteria:\n\n* High-dose ascorbic acid or acetaminophen \\> 4g\u002Fday\n* Physical or mental health condition precluding continuous wear of the continuous glucose monitor, as judged by the physician","ALL","18 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24],"NA","Main objective:\n\nThe goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit.\n\nOn admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position.\n\nSensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels.\n\nSensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose.\n\nPatients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows.\n\nCalibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter.\n\nCalibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol\u002FL).\n\nCalibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol\u002FL) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol\u002FL).\n\nHypothesis:\n\n* Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors.\n* Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%).\n\nFurther objectives:\n\nTo evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety.\n\nTo identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.",[27,28,29,30,31,32],"CGM","Intensive Care (ICU)","Liver Transplant Surgery","Solid Organ Transplantation","Major Abdominal Surgeries","Diabetes (Insulin-requiring, Type 1 or Type 2)","RECRUITING","2026-05-20",{"date":36,"type":37},"2026-05-28","ACTUAL",{"date":39,"type":37},"2026-01-14",{"date":41,"type":21},"2027-04",{"name":43,"class":44},"Institute for Clinical and Experimental Medicine","OTHER_GOV",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100619040","intraoperative-multimodal-monitoring-as-a-means-in-reducing-the-duration-of-mechanical-ventilation-in-high-risk-patients-undergoing-major-abdominal-procedures---a-pilot-study-100619040","NCT07339449","Intraoperative Multimodal Monitoring as a Means in Reducing the Duration of Mechanical Ventilation in High-Risk Patients Undergoing Major Abdominal Procedures - A Pilot Study","IMMEDIUM","Inclusion Criteria:\n\n* aged 50 years or older\n* scheduled for elective major abdominal surgery, specifically those classified as ASA II and ASA III\n\nExclusion Criteria:\n\n* patient refusal;\n* memory impairment (psychosis);\n* known or suspected electroencephalo-graphic abnormalities (such as epilepsy or previous brain surgery);\n* chronic use of psy-choactive medication;\n* urgent or emergent procedures;\n* body mass index (BMI) below 18 kg\u002Fm2 or above 35 kg\u002Fm2;\n* persistent arrhythmias including atrial fibrillation and undulation;\n* documented NYHA class III-IV heart failure or a preoperative left ventricular ejection fraction below 30%;\n* valvular disease involving aortic and\u002For mitral stenosis or regurgita-tion;\n* liver diseases such as decompensated cirrhosis and coagulopathies;\n* anticipated operation duration exceeding six hours.","50 Years",{"count":55,"type":21},100,[24],"This study will include patients aged 50 and older scheduled for elective abdominal oncologic surgery, classified as ASA II and III due to increased anaesthetic and surgical risk. Gender will not be a stratification factor. Exclusion criteria include patient refusal, memory impairment, psychosis, known or suspected EEG abnormalities, chronic psychoactive medication use, urgent procedures, BMI below 18 kg\u002Fm² or above 35 kg\u002Fm², persistent arrhythmias, NYHA class III-IV heart failure, valvular disease, liver diseases, and anticipated surgery duration over six hours. Eligible patients must sign an informed consent form one day prior to surgery. Demographic data collected will include age, sex, operation type, comorbidities, ASA status, height, weight, and BMI. Randomisation will occur before the study begins with a sample size of 100 subjects based on a pilot study of 5 patients per group.\n\nPremedication and Monitoring: Patients will receive premedication per institutional protocol, which includes intramuscular midazolam. Intraoperative monitoring follows randomisation allocation. The control group will have standard measurements, including invasive pressure and ECG. Data collection will be handled by designated team members who will archive anaesthesia charts. After intubation, patients will be ventilated with 6-8 ml\u002Fkg of predicted body weight and a fresh gas flow of 1 L\u002Fmin.\n\nIntervention Group Protocol: In the intervention group, monitoring will be established via radial artery cannulation under local anaesthesia, using LiDCOrapid®, Rainbow®, and Hb attachments. Baseline MAP and CO values will be recorded, with DO2 calculated automatically. Sensors will be positioned to monitor anaesthetic depth and rSO2 before pre-oxygenation. A noradrenaline infusion will maintain venous tone.\n\nAnaesthesia will use TCI with propofol and sufentanil, targeting specific values based on age groups. The primary goal is to maintain an rSO2 of at least 85% of baseline. If rSO2 falls below this threshold, a DO2 optimisation protocol will be initiated, adjusting conditions and administering fluids and medications as necessary.\n\nControl Group Protocol: In the control group, propofol and sufentanil will be administered as previously outlined with adjustments based on intraoperative responses and awareness. Rocuronium bromide will be used for neuromuscular blockade, with monitoring and administration of fluids managed by the attending anaesthesiologist.\n\nData Recording: All data during procedures will be recorded digitally or manually, and post-procedure data will be downloaded for analysis. Patients will be transferred to the ICU for postoperative monitoring.\n\nLaboratory Analysis: Blood samples for routine analysis will be collected at three time points: prior to surgery, upon ICU admission, and 24 hours after. Parameters assessed include complete blood count, electrolyte levels, PT, aPTT, fibrinogen, blood gas parameters, lactate, troponin I, and NTproBNP.\n\nOutcome Measurements: Both groups will be monitored for duration of anaesthesia, drug administration, fluid volume, postoperative complications, mortality rates, and ICU length of stay (LOS). Continuous variables will be reported using descriptive statistics or interquartile ranges, while categorical variables will be shown as counts and percentages.\n\nStatistical analysis will be performed using Mann Whitney U test for continuous variables, repeated measures ANOVA for group comparisons, and chi-squared tests for categorical variables. ANCOVA will be employed to compare clinical outcomes with age as a covariate. The software package jamovi v2.5.3 will be utilized for statistical analysis with a significance level set at p \\\u003C 0.05.",[31,59],"Mechanical Ventilation",[61,62,63,64,65],"Abdominal surgery","minimally invasive","cardiac output","cerebral oximetry","multimodal monitoring","2026-01-15",{"date":68,"type":37},"2026-01-16",{"date":70,"type":37},"2025-08-01",{"date":72,"type":21},"2027-06-30",{"name":74,"class":75},"University Hospital Dubrava","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100618277","metabolic-and-muscle-profile-in-icu-survivors-100618277","NCT07329530","Metabolic and Muscle Profile in ICU Survivors","Characterisation of the Inflammatory, Metabolic, and Mitochondrial Profiles in the Context of Post-Intensive Care Muscle Dysfunction","IM3SI","Inclusion Criteria\n\n* Critical illness:\n* anticipated ICU stay \\>= 7 days\n* Major abdominal surgery\n* elective surgery\n\nExclusion Criteria:\n\n* Active malignancy\n* Inherited metabolic disorder\n* Known muscle disease\n* Pregnancy\n* Patient refusal\n* Patient unable to express informed consent (dementia, confusion)\n* Known coagulation disorder (cirrhosis, genetic coagulopathy) or thrombocytopenia \\\u003C 100,000\u002Fmm³ on the day of biopsy, anemia with hemoglobin \\\u003C 9 g\u002FdL on the day of biopsy, or treatment with anticoagulant agents (contraindication to muscle biopsies only)\n* Pacemaker or other implanted electronic device (contraindication to bioelectrical impedance analysis only)\n* Oxygen therapy (contraindication to indirect calorimetry during spontaneous ventilation)",{"count":55,"type":21},[24],"More and more patients survive a critical illness requiring admission to the intensive care unit, but they may be left with sequelae that are independent of the initial pathology. From a physical standpoint, the most visible complication is intensive care unit-acquired muscle weakness. A major factor in the development and persistence of muscle dysfunction appears to be the inflammatory response and the neuroendocrine stress response triggered by the initial critical insult. Persistence of inflammation beyond ICU discharge has been demonstrated in several studies. In response to inflammation, there is also increased oxidative stress associated with mitochondrial dysfunction.\n\nThe objectives of the present study are therefore:\n\nto determine whether the broad inflammatory and metabolic profile of patients who have survived an ICU stay can predict the trajectory of muscle performance over the three months following ICU discharge; to compare this profile and muscle performance with those of non-critically ill surgical patients who have undergone a standardized inflammatory stress of lower intensity than that associated with critical illness; to investigate mitochondrial function in skeletal striated muscle after ICU stay, in light of the inflammatory and metabolic profile; to assess whether abnormalities in mitochondrial function also affect tissues other than skeletal muscle, in particular circulating blood mononuclear cells.",[88,31],"Critical Illness","2026-01-08",{"date":91,"type":37},"2026-01-12",{"date":93,"type":37},"2025-12-01",{"date":95,"type":21},"2029-04-01",{"name":97,"class":75},"Anne-Françoise Rousseau",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":45},"100608309","assessment-of-respiratory-drive-and-inspiratory-effort-across-pressure-support-levels-in-patients-after-major-abdominal-surgery-100608309","NCT07199881","Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery","Inclusion Criteria:\n\n* Adult patients (≥18 years) admitted to the surgical ICU\n* Recent major abdominal surgery (intra-peritoneal operation without primary thoracic involvement, including luminal resection and\u002For resection of a gastrointestinal solid organ) requiring postoperative ICU care\n* Receiving invasive mechanical ventilation in pressure support ventilation (PSV) mode at the time of enrollment\n* Duration of invasive mechanical ventilation \\>48 hours\n* Clinically stable, with no plan for extubation within 6 hours of study enrollment, defined by all of the following: Respiratory rate \\\u003C35 breaths\u002Fmin, SpO₂ ≥90%, Heart rate \\\u003C140 bpm, No visible accessory muscle use, Hemodynamically stable without escalation of vasopressor support during the past hour, Able to tolerate short-term adjustments in PSV level as per protocol\n\nExclusion Criteria:\n\n* Known neuromuscular disease affecting respiratory muscle function\n* Hemodynamic instability requiring escalation of vasopressor support\n* Severe hypoxemic respiratory failure requiring Positive End-Expiratory Pressure (PEEP) \\>10 cmH₂O or FiO₂ \\>60%\n* Deep sedation (Richmond Agitation-Sedation Scale \\[RASS\\] score \\\u003C -3) or ongoing neuromuscular blockade\n* History of chronic obstructive pulmonary disease (COPD) or other obstructive lung disease",{"count":105,"type":21},40,[24],"This physiological observational study will assess respiratory drive and inspiratory effort across varying levels of pressure support ventilation (PSV) in adult surgical ICU (SICU) patients after major abdominal surgery. By using non-invasive bedside indices (airway occlusion pressure at 100 ms after the onset of inspiration \\[P0.1\\], maximum negative occlusion pressure \\[Pocc\\], and pressure muscle index \\[PMI\\]), we aim to quantify how patients adapt to changes in ventilatory support and determine patterns of under- and over-assistance. Findings may inform optimal titration of PSV to reduce complications and improve clinical outcomes.",[109,59,31],"Inspiratory Effort",[111,112,113,114,115],"Pressure support ventilation","respiratory drive","inspiratory effort","mechanical ventilation","Major Abdominal Surgery","2025-11-15",{"date":118,"type":37},"2025-11-18",{"date":120,"type":37},"2025-10-31",{"date":122,"type":21},"2027-09-30",{"name":124,"class":75},"Mahidol University"]