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

NCT07755033 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1120-02
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis; Nutrition; Gut -Microbiota

Keywords

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Length of ICU Stay

  Total number of days from ICU admission to ICU discharge.

  Up to 90 days

Study Arms (2)

Individualized Nutrition Group

EXPERIMENTAL

The total daily dose of enteral nutrition will be adjusted dynamically according to the patient's daily metabolic measurements.

Dietary Supplement: Individualized Enteral Nutrition Formula

Standard Nutrition Group

ACTIVE COMPARATOR

A standardized enteral nutrition formula will be provided following the routine clinical protocol as recommended by current guidelines.

Dietary Supplement: Standard Enteral Nutrition Formula

Interventions

Individualized Enteral Nutrition Formula DIETARY_SUPPLEMENT

Individualized Enteral Nutrition Formula Based on Daily Metabolic Measurements

Individualized Nutrition Group

Standard Enteral Nutrition Formula DIETARY_SUPPLEMENT

Standardized enteral nutrition formula will be administered according to the routine clinical protocol recommended by current guidelines.

Standard Nutrition Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Medical Association: lead

Related Publications (1)

• Xi F, You Y, Ding W, Gao T, Cao Y, Tan S, Yu W. Association of longitudinal changes in skeletal muscle mass with prognosis and nutritional intake in acutely hospitalized patients with abdominal trauma: a retrospective observational study. Front Nutr. 2023 May 31;10:1085124. doi: 10.3389/fnut.2023.1085124. eCollection 2023.

  PMID: 37324740 RESULT

MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Ying Xu, MD

CONTACT

+86 13505159362; xuying.0110@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nanjing Drum Tower Hospital

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): July 27, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share