[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"organ-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:organ-dysfunction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,90,127],{"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":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100645828","thoracic-epidural-analgesia-for-acute-pancreatitis-with-early-organ-dysfunction-100645828",false,"NCT07697690","Thoracic Epidural Analgesia for Acute Pancreatitis With Early Organ Dysfunction","Effect of Thoracic Epidural Analgesia on Organ Support Burden in Patients With Acute Pancreatitis and Early Organ Dysfunction: A Single-Center Randomized Controlled Trial","TEA-APOD","Inclusion Criteria:\n\nInclusion Criteria:\n\n1. Age 18 to 75 years, inclusive.\n2. Diagnosis of acute pancreatitis based on at least two of the following three criteria: typical acute upper abdominal pain; serum amylase and\u002For lipase at least three times the upper limit of normal; or imaging findings consistent with acute pancreatitis.\n3. Time from symptom onset to randomization of 72 hours or less.\n4. Early respiratory, cardiovascular, or renal organ dysfunction, defined as a SOFA-2 subscore of 2 or greater in at least one of these three organ systems, requiring ICU admission for continuous monitoring and treatment. The SOFA-2 score will be calculated using the worst available values during the 24 hours before randomization; for participants admitted to the ICU for less than 24 hours, values available since ICU admission will be used. The organ dysfunction must be newly developed or clearly worsened from the participant's previous stable baseline.\n5. Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation.\n2. Chronic pancreatitis or acute pancreatitis associated with a pancreatic tumor.\n3. Prior retroperitoneal drainage, endoscopic drainage, surgical necrosectomy, or other invasive intervention before randomization that may substantially alter the natural course of the disease.\n4. Invasive mechanical ventilation before randomization.\n5. Any contraindication to thoracic epidural analgesia, including allergy to local anesthetics; infection at the puncture site; epidural abscess or central nervous system infection; severe spinal deformity or prior spinal surgery that prevents catheterization; intracranial hypertension or severe central nervous system disease; uncorrected coagulation disorder; or anticoagulant or antiplatelet therapy that does not meet neuraxial safety requirements.\n6. Uncorrected shock or persistent hemodynamic instability despite adequate fluid resuscitation and vasoactive drug support.\n7. End-stage renal disease requiring maintenance dialysis before randomization.\n8. Participation in another interventional clinical study within the previous 3 months.\n9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","Acute pancreatitis may cause early respiratory, cardiovascular, or renal dysfunction and may require intensive care and organ support. Thoracic epidural analgesia may improve pain control, reduce systemic opioid exposure, and facilitate gastrointestinal recovery; however, its effect on overall organ support burden remains uncertain.\n\nThis is a single-center, prospective, randomized, open-label, parallel-group clinical trial. A total of 150 adults with acute pancreatitis within 72 hours of symptom onset and early respiratory, cardiovascular, or renal dysfunction will be randomized in a 1:1 ratio to receive either ropivacaine-only thoracic epidural analgesia plus standard care or standardized conventional analgesia plus standard care.\n\nThe primary outcome is alive and organ support-free days through day 14 after randomization. Secondary and exploratory outcomes include alive and organ support-free days through day 28, organ dysfunction-free days, ventilator-free days, renal replacement therapy-free days, vasoactive drug-free days, 28-day mortality, pain scores, systemic opioid exposure, gastrointestinal and nutritional outcomes, intra-abdominal pressure, inflammatory markers, complications, length of stay, hospital costs, and adverse events related to thoracic epidural analgesia.",[28,29,30],"Organ Dysfunction","Organ Support","Acute Pancreatitis (AP)",[32,33,34,35,36],"Thoracic epidural block","Ropivacaine","Organ support-free days","Opioid consumption","acute pancreatitis","NOT_YET_RECRUITING","2026-07-19",{"date":40,"type":41},"2026-07-21","ACTUAL",{"date":43,"type":22},"2026-08-01",{"date":45,"type":22},"2028-09-01",{"name":47,"class":48},"First People's Hospital of Chenzhou","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100602123","icu-background-early-awareness-for-critical-deterioration-100602123","NCT07119411","ICU Background Early Awareness for Critical deterioratiON","ICU Background Early Awareness for Critical deterioratiON (BEACON)","BEACON","Inclusion Criteria:\n\n* admission to intensive care unit\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* presence of documented refused general consent form (at database closure)\n* admission for the sole purpose of dying\u002Forgan donation or evaluation of such",true,{"count":59,"type":22},1962,"OBSERVATIONAL","The study will compare ICU sub-units, those with additional support of a clinician awareness system, ICU Beacon, and those receiving the standard of care. The win-ratio composite outcome will be assessed by comparing patients by study group and stratified by APACHE score at admission.",[63,64,65,28,66],"Respiratory Failure","Circulatory Failure","Mortality","Organ Failure, Multiple",[68,69,70,71,72,73,74,75,76,77,78],"icu","respiratory failure","circulatory failure","early warning system","prevention","prediction","risk prediction","organ failure","multi-organ failure","win-ratio","ICU Beacon","RECRUITING","2026-06-12",{"date":82,"type":41},"2026-06-15",{"date":84,"type":41},"2025-12-01",{"date":86,"type":22},"2027-11-01",{"name":88,"class":48},"ETH Zurich",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":98,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100598171","organ-dysfunction-score-for-obstetric-patients-100598171","NCT07068022","Organ Dysfunction Score for Obstetric Patients","Development and Validation of an Obstetric Organ Dysfunction Score to Predict Mortality in Intensive Care Unit: A Multicenter, Prospective, Cohort Study","SOFA-OBS","Inclusion Criteria:\n\nAll of the following=\n\n* Pregnant (at any gestational age) or post-partum patients (at ≤3 days postpartum)\n* ≥ 18 years old\n* Requiring admission to ICU for any reason\n* Staying in the ICU for ≥ 24h\n* Giving her consent to participate. Patients will be recruited consecutively until reaching the sample size.\n\nExclusion Criteria:\n\nAny of the following=\n\n* Patients \\\u003C18 years old\n* Non-pregnant patients\n* ≥ 4 days postpartum\n* Patients or surrogates not giving consent to participate\n* ICU-LOS \\\u003C 24 h","FEMALE",{"count":100,"type":22},130,"The goal of this observational study is to develop and evaluate an organ dysfunction score adapted to pregnancy and early puerperium (SOFA-OBS) that also incorporates a non-invasive tool to evaluate respiratory function (pulse oximeter).\n\nThe main question it aims to answer is: Does an organ dysfunction score adapted to pregnant and postpartum patients have a higher capacity to predict mortality than a non-adjusted organ dysfunction score? Participants: Patients requiring ICU (Intensive Care Units) admission, who are either pregnant or postpartum (up to 3 days after giving birth). The investigators aimed to include 130 participants.\n\nThe investigators will only collect participants' data and laboratory results that ICU doctor usually need for clinical practice. No additional interventions are required. Moreover, the investigators will evaluate if measuring participants' oxygenation through a non-invasive tool (pulse oximeter) is equally effective as measuring oxygenation by an arterial puncture.\n\nBackground: When managing severely ill patients in ICU, the investigators often use what it is called scores. Scores refer to a numerical value assigned to a patient's condition, which often predict outcome. The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assess severity of organ dysfunction (in liver, kidney, blood pressure, respiratory, neurologic and platelets). It also identifies patients with severe infections (sepsis) and patients with bad outcomes.\n\nPatients undergoing pregnancy or early postpartum develop physiological changes, such us a decrease in creatinine (a laboratory test measuring kidney function) and a decrease in blood pressure during the second trimester. These changes are not considered by the SOFA score. Actually, there is not an organ dysfunction score adapted to pregnant\u002Fpostpartum patients to be used in the ICU. Moreover, a blood sample taken by arterial puncture is required to evaluate respiratory function by the SOFA score, which is a painful procedure. Instead, the investigators could evaluate respiratory function using a pulse oximeter, which measures peripheral oxygen saturation without needing an arterial puncture.\n\nPotential benefits: A SOFA-OBS would hopefully become a more precise tool than general SOFA to evaluate organ dysfunction and to predict outcome among these patients. It would also help to detect sepsis earlier and treat it promptly, which might help reducing its mortality.",[103,104,28,105,106],"Pregnancy","Postpartum","Critical Care, Intensive Care","Sepsis",[108,103,104,109,110,111,112,113,114,65,106,115,116],"Sequential Organ Failure Assessment score","Critical care","Intensive Care Unit","Creatinine","Peripheral oxygen saturation","Hypotension","Maternal mortality","Septic shock","Multicenter study","2026-04-22",{"date":119,"type":41},"2026-04-28",{"date":121,"type":41},"2025-10-06",{"date":123,"type":22},"2027-02-28",{"name":125,"class":48},"Daniela Vasquez",18,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100599512","the-effect-of-the-timing-of-supplemental-parenteral-nutrition-on-the-prognosis-of-critically-ill-patients-t-spn-100599512","NCT07085455","The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN)","The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN): A Multicenter Randomized Controlled Trial","Inclusion Criteria：\n\n1. Age ≥ 18 years\n2. Failure of one or more organ systems within 24 hours of ICU admission, defined as Sequential Organ Failure Assessment (SOFA) score ≥ 2 in any single organ system\n3. Expected ICU stay \\> 72 hours\n4. Able to initiate early enteral nutrition (EN) within 48 hours of ICU admission\n5. Enteral nutrition providing \\\u003C50% of target caloric requirements within 72 hour Exclusion Criteria\n\n1.Full oral intake or tolerance of full-dose EN; no need for SPN 2.Receiving palliative care or expected to die within 72 hours 3.Pregnant or lactating women 4.Long-term use of systemic corticosteroids or other immunosuppressive agents 5.Known malignancy currently receiving radiotherapy or chemotherapy 6.Contraindications to parenteral nutrition (PN) 7.Participation in another interventional clinical trial",{"count":135,"type":22},946,[25],"This multicenter, randomized controlled trial aims to evaluate whether early initiation of supplemental parenteral nutrition (SPN) (on day 4 of ICU admission) compared to late initiation (on day 8) can reduce 28-day all-cause mortality in critically ill patients. Secondary objectives include assessing the effects of early SPN on long-term functional outcomes (2-year EQ-5D-5L scores), mortality at various timepoints (ICU, 28-day, 90-day, 180-day, and 2-year), ICU length of stay, serum prealbumin levels (days 8 and 28), skeletal muscle measurements (diaphragm thickness, biceps, quadriceps, and rectus femoris cross-sectional area), incidence of ICU-acquired infections, adverse events (e.g., hyperglycemia, hypoglycemia, dyslipidemia, liver dysfunction), and ventilator-free days within 28 days.\n\nEligible patients are adults (≥18 years) with at least one organ failure (SOFA score ≥2) within 24 hours of ICU admission, expected to remain in the ICU for \\>72 hours, and unable to reach 50% of caloric target via enteral nutrition (EN) within the first 72 hours. A total of 946 patients will be enrolled and randomized to receive either early SPN (day 4) or late SPN (day 8) in addition to standard EN. Follow-up will include in-hospital assessments and telephone follow-ups at 28, 90, 180 days, and 2 years. The study hypothesizes that early SPN may improve short-term survival and nutritional\u002Fmuscle status, though its impact on long-term quality of life remains to be determined.",[139,28,140,141],"Critical Illness","Enteral Nutrition Intolerance","Inadequate Nutritional Intake",[143,144,145,146,147,148],"Nutritional support","Supplementary parenteral nutrition","Early enteral nutrition","Severe patients","critical care","intensive care","2025-09-09",{"date":151,"type":41},"2025-09-15",{"date":149,"type":41},{"date":154,"type":22},"2029-07-20",{"name":156,"class":48},"Dong Zhang",2]