[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651038":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":26,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":63,"whyStopped":26,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":26},{"fullName":5,"class":6},"Chinese Medical Association","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Individualized Nutrition Group","EXPERIMENTAL","The total daily dose of enteral nutrition will be adjusted dynamically according to the patient's daily metabolic measurements.",[13],"Dietary Supplement: Individualized Enteral Nutrition Formula",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Nutrition Group","ACTIVE_COMPARATOR","A standardized enteral nutrition formula will be provided following the routine clinical protocol as recommended by current guidelines.",[19],"Dietary Supplement: Standard Enteral Nutrition Formula",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Individualized Enteral Nutrition Formula","Individualized Enteral Nutrition Formula Based on Daily Metabolic Measurements",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Enteral Nutrition Formula","Standardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ying Xu, MD","CONTACT","+86 13505159362","xuying.0110@163.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Juanhong Shen","Nanjing Drum Tower Hospital","100651038","personalized-nutritional-formula-for-icu-patients-a-study-on-prognosis-and-multidimensional-health-markers-100651038",false,"NCT07755033","Personalized Nutritional Formula for ICU Patients: A Study on Prognosis and Multidimensional Health Markers","The Effect of an Individualized Nutrition Formula on Clinical Prognosis, Intestinal and Pulmonary Microbiota, Serum Metabolomics, and Macronutrient Balance in Critically Ill Patients: A Prospective Interventional Study","Inclusion Criteria:\n\nCritically ill patients admitted to the intensive care unit (ICU) who meet the indications for enteral nutrition support.\n\nAge ≥ 18 years. APACHE II score \\> 8 at ICU admission. Expected ICU length of stay \\> 7 days.\n\nExclusion Criteria:\n\nAge \\\u003C 18 years. Pregnancy or lactation. Known allergy to any component of the enteral nutrition formula. Gastrointestinal bleeding, incomplete intestinal obstruction, or other conditions precluding full enteral nutrition.\n\nKnown severe thyroid dysfunction (e.g., thyrotoxic crisis, myxedema coma, or uncontrolled hyperthyroidism\u002Fhypothyroidism).\n\nChronic end-stage organ failure, including: New York Heart Association (NYHA) Class IV heart failure, Child-Pugh Class C cirrhosis, or Stage 5 chronic kidney disease (CKD).\n\nPrimary intestinal diseases (e.g., Crohn's disease, ulcerative colitis, or intestinal malignancies), short bowel syndrome, or history of extensive small bowel resection (residual small intestine \\\u003C 100 cm).\n\nMetabolic disorders that significantly affect nutritional metabolism (e.g., Sheehan's syndrome, or other conditions with major metabolic consequences) as determined by the investigator.","ALL","18 Years",{"count":51,"type":52},1200,"ESTIMATED","INTERVENTIONAL",[55],"NA","This study aims to evaluate the effects of an individualized enteral nutrition formula on clinical outcomes in critically ill adult patients in the intensive care unit (ICU). Participants will be randomly assigned to one of two groups: the individualized nutrition group or the standard nutrition group. In the individualized group, the total daily amount of enteral nutrition will be calculated and adjusted daily based on the patient's resting energy expenditure (measured by indirect calorimetry) and serum protein levels. In the standard group, a fixed-dose formula will be administered according to routine clinical protocols recommended by current guidelines. The intervention will be initiated within 48 hours of ICU admission and continued for up to 14 days or until ICU discharge. The study will assess clinical prognosis, as well as changes in gut and pulmonary microbiota, serum metabolomics, and macronutrient balance. The findings may provide evidence for personalized nutrition strategies in critically ill patients.",[58,59,60],"Sepsis","Nutrition","Gut -Microbiota",[62],"Critical Illness","NOT_YET_RECRUITING","2026-08-05",{"date":66,"type":67},"2026-08-10","ACTUAL",{"date":69,"type":52},"2026-07-28",{"date":71,"type":52},"2028-12-31",{"name":5,"class":6}]