Personalized Nutritional Formula for ICU Patients: A Study on Prognosis and Multidimensional Health Markers

Sponsor
Chinese Medical Association
Study ID
NCT07755033
Status
Not Yet Recruiting

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Conditions

  • Gut -Microbiota
  • Nutrition
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Individualized Enteral Nutrition Formula — DIETARY_SUPPLEMENT
    Individualized Enteral Nutrition Formula Based on Daily Metabolic Measurements
  • Standard Enteral Nutrition Formula — DIETARY_SUPPLEMENT
    Standardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Jul 28, 2026
Status verified
Jul 2026
Primary completion
Jul 27, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Individualized Nutrition Group
    The total daily dose of enteral nutrition will be adjusted dynamically according to the patient's daily metabolic measurements.
  • Active Comparator: Standard Nutrition Group
    A standardized enteral nutrition formula will be provided following the routine clinical protocol as recommended by current guidelines.

Primary Outcome Measure

Length of ICU Stay [ Time Frame: Up to 90 days ]

Central Contacts

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