About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Critically ill patients who can initiate early enteral nutrition
Trial design
Cohort
Prospective
Treatments tested in this trial
Not applicable- observational study
Other interventionThis is a prospective observational study and does not involve any intervention measures
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
28-day mortality
Whether the patient died on the 28th day after being admitted to the ICU
Nutritional adequacy rate on the 7th day
The probability of achieving 80% of the calorie target (25 kcal/kg/day) in enteral nutrition on the 7th day in the ICU
Length of stay in the ICU
The duration (in days) of the subjects' hospital stay in the ICU
28-day ventilator-free days
The number of days within the first 28 days after enrollment during which the patient was alive and free from invasive mechanical ventilation.
Sponsors and contacts
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