[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599512":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early SPN Group","EXPERIMENTAL","Patients in this group will receive supplemental parenteral nutrition (SPN) starting on day 4 after ICU admission, in addition to standard enteral nutrition (EN).",[13],"Dietary Supplement: Early Supplemental Parenteral Nutrition (SPN)",{"label":15,"type":16,"description":17,"interventionNames":18},"Late SPN Group","ACTIVE_COMPARATOR","Patients in this group will receive SPN starting on day 8 after ICU admission, in addition to standard EN.",[19],"Dietary Supplement: Late Supplemental Parenteral Nutrition (SPN)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Early Supplemental Parenteral Nutrition (SPN)","SPN is initiated on ICU day 4 if enteral nutrition remains \\\u003C50% of the target caloric requirement. Nutrition support is guided by protocol",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Late Supplemental Parenteral Nutrition (SPN)","SPN is initiated on ICU day 8 if enteral nutrition remains \\\u003C50% of the target caloric requirement. Nutrition support is guided by the same protocol as in the early SPN group.",[15],[32],{"name":33,"affiliation":5,"role":34},"dong zhang","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"yanhua li","CONTACT","86-15804301738","liyanhua@jiu.edu.cn",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"youquan wang","86-15584299391","wangyq20@mails.jlu.edu.cn",[46,61],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"NOT_YET_RECRUITING","Changchun","Jilin","130021","China","CN",{"type":54,"coordinates":55},"Point",[56,57],125.32278,43.88,{"lat":57,"lon":56},[60],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":26},{"facility":5,"status":62,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":63,"geoPoint":65,"contacts":26},"RECRUITING",{"type":54,"coordinates":64},[56,57],{"lat":57,"lon":56},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Dong Zhang","chief physician","100599512","the-effect-of-the-timing-of-supplemental-parenteral-nutrition-on-the-prognosis-of-critically-ill-patients-t-spn-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":80,"type":81},946,"ESTIMATED","INTERVENTIONAL",[84],"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.",[87,88,89,90],"Critical Illness","Organ Dysfunction","Enteral Nutrition Intolerance","Inadequate Nutritional Intake",[92,93,94,95,96,97],"Nutritional support","Supplementary parenteral nutrition","Early enteral nutrition","Severe patients","critical care","intensive care","2025-09-09",{"date":100,"type":101},"2025-09-15","ACTUAL",{"date":98,"type":101},{"date":104,"type":81},"2029-07-20",{"name":68,"class":6},2]