Association of Biomarkers and Gastric Antral Motility Index With Feeding Intolerance in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable- observational study.
- Who it may be relevant to
- Registry conditions: Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICU. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association of Biomarkers and Gastric Antral Motility Index With Feeding Intolerance in Critically Ill Patients: the BGM-FI Study
Overview
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
Interventions
- Other Not applicable- observational study
This is a prospective observational study and does not involve any intervention measures
Primary outcome measures
- The subject developed feeding intolerance within 7 days of the ICU [Time frame: The first to seventh days in the ICU]
- Pragmatic Definition of Enteral Feeding Intolerance (EFI) - Sensitivity Analysis of the Primary Outcome [Time frame: From enrollment (ICU admission) through day 7 of enteral nutrition]
Secondary outcome measures (6)
- 28-day mortality [Time frame: From the 1st to the 28th day after admission to the ICU]
- Nutritional adequacy rate on the 7th day [Time frame: On the seventh day of admission to the ICU]
- Length of stay in the ICU [Time frame: From enrollment to the patient's departure from the ICU (up to 90 days)]
- 28-day ventilator-free days [Time frame: From enrollment (ICU admission) through day 28]
- Incidence of Gastric Retention [Time frame: From enrollment (ICU admission) through day 7 of enteral nutrition]
- Incidence of Diarrhea [Time frame: From enrollment (ICU admission) through day 7 of enteral nutrition]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT07178626 · BGM-FI