[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dong Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100599512",false,"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","ALL","18 Years",{"count":18,"type":19},946,"ESTIMATED","INTERVENTIONAL",[22],"NA","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.",[25,26,27,28],"Critical Illness","Organ Dysfunction","Enteral Nutrition Intolerance","Inadequate Nutritional Intake",[30,31,32,33,34,35],"Nutritional support","Supplementary parenteral nutrition","Early enteral nutrition","Severe patients","critical care","intensive care","RECRUITING","2025-09-09",{"date":39,"type":40},"2025-09-15","ACTUAL",{"date":37,"type":40},{"date":43,"type":19},"2029-07-20",{"name":45,"class":46},"Dong Zhang","OTHER",2,""]