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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Not applicable- observational study

    Other intervention

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

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Critically ill patients who initiated enteral nutrition early1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The first to seventh days in the ICU
2

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.

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

Secondary outcomes

1

28-day mortality

Whether the patient died on the 28th day after being admitted to the ICU

Time frame
From the 1st to the 28th day after admission to the ICU
2

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

Time frame
On the seventh day of admission to the ICU
3

Length of stay in the ICU

The duration (in days) of the subjects' hospital stay in the ICU

Time frame
From enrollment to the patient's departure from the ICU (up to 90 days)
4

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.

Time frame
From enrollment (ICU admission) through day 28

Other outcomes

Sponsors and contacts

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