Association of Biomarkers and Gastric Antral Motility Index With Feeding Intolerance in Critically Ill Patients

NCT07178626 | Enrolling By Invitation DMC

• 1 other identifier: BGM-FI
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

When the subjects are admitted to the department, the researchers will monitor potential biomarkers of gastrointestinal injury before administering enteral nutrition (a small amount of blood is drawn, serum is separated by centrifugation, and the serum sample is frozen for final centralized biomarker detection), and measure the antral movement index under ultrasound (300ml of warm water is injected into the stomach before measurement, and then the antral movement is observed for 6 minutes) Then, monitor whether the patient has developed feeding intolerance within 7 days of the ICU

Conditions

Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICU

Outcome Measures

Primary Outcomes (2)

• The subject developed feeding intolerance within 7 days of the ICU

  The subject developed feeding intolerance (FI) within 7 days of the ICU FI is defined as either: * intolerance to EN due to any clinical reason (e.g., vomiting (any visible regurgitation of gastric content irrespective of the amount), high gastric residual volume (a single volume exceeds 200 ml), diarrhea (having three or more loose or liquid stools per day with a stool weight greater than 200-250 g/day (or greater than 250 ml/day)), gastrointestinal GI bleeding (any bleeding into the GI tract lumen, confirmed by macroscopic presence of blood in vomited fluids, gastric aspirate or stool), etc.), or * FI should be considered present if at least 20 kcal/kg BW/day via enteral route cannot be reached within 72 h of feeding attempt or if enteral feeding has to be stopped for whatever clinical reason.

  The first to seventh days in the ICU

• Pragmatic Definition of Enteral Feeding Intolerance (EFI) - Sensitivity Analysis of the Primary Outcome

  This outcome represents a sensitivity analysis for the primary outcome of feeding intolerance. EFI is pragmatically defined as a clinician's decision to reduce the prescribed amount of enteral nutrition (EN) specifically because features of gastrointestinal dysfunction appeared during feeding. Results from this pragmatic definition will be analyzed to test the robustness of the primary outcome and will be interpreted only as supportive evidence, not as separate primary or secondary outcomes.

  From enrollment (ICU admission) through day 7 of enteral nutrition

Secondary Outcomes (6)

• 28-day mortality

  From the 1st to the 28th day after admission to the ICU

• Nutritional adequacy rate on the 7th day

  On the seventh day of admission to the ICU

• Length of stay in the ICU

  From enrollment to the patient's departure from the ICU (up to 90 days)

• 28-day ventilator-free days

  From enrollment (ICU admission) through day 28

• Incidence of Gastric Retention

  From enrollment (ICU admission) through day 7 of enteral nutrition

Study Arms (1)

Critically ill patients who initiated enteral nutrition early

Critically ill patients who initiated enteral nutrition early

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

This is a prospective observational study and does not involve any intervention measures

Critically ill patients who initiated enteral nutrition early

Eligibility Criteria

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

Study Population

Critically ill patients who can initiate early enteral nutrition

You may qualify if:

• Age ≥18 years
• Presence of one or more organ system failures within 24 hours of ICU admission (SOFA score ≥2)
• Expected ICU stay \>48 hours
• Inability to take oral nutrition
• No contraindications to enteral nutrition (EN)

You may not qualify if:

• Patients who have already received enteral nutrition prior to gastric antral motility measurement or biomarker collection
• Receiving palliative care with expected death within 48 hours
• Pregnancy
• Participation in another clinical trial

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)