Gut -Microbiota, Nutrition, Sepsis
Conditions
Keywords
Critical Illness
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTIndividualized Enteral Nutrition Formula
Individualized Enteral Nutrition Formula Based on Daily Metabolic Measurements
DIETARY_SUPPLEMENTStandard Enteral Nutrition Formula
Standardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines.
Sponsors
Chinese Medical Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Critically ill patients admitted to the intensive care unit (ICU) who meet the indications for enteral nutrition support. Age ≥ 18 years. APACHE II score \> 8 at ICU admission. Expected ICU length of stay \> 7 days.
Exclusion criteria
Age \< 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. Known severe thyroid dysfunction (e.g., thyrotoxic crisis, myxedema coma, or uncontrolled hyperthyroidism/hypothyroidism). Chronic 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). Primary 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 \< 100 cm). Metabolic disorders that significantly affect nutritional metabolism (e.g., Sheehan's syndrome, or other conditions with major metabolic consequences) as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stay | Up to 90 days | Total number of days from ICU admission to ICU discharge. |
Contacts
CONTACTYing Xu, MD
Outcome results
None listed