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

Condition(s) studied

Investigational drug(s) / intervention(s)

Not applicable- observational study: This is a prospective observational study and does not involve any intervention measures

Study 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

Eligibility

Primary outcome measure(s)

• The subject developed feeding intolerance within 7 days of the ICU — The first to seventh days in 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.
• Pragmatic Definition of Enteral Feeding Intolerance (EFI) - Sensitivity Analysis of the Primary Outcome — From enrollment (ICU admission) through day 7 of enteral nutrition
  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.

Trial sites (1)

More The First Hospital of Jilin University trials in China