Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness

Jilin University

Status: Not yet enrolling

Conditions: Adult; Patients Admitted to the ICU; Expected Hospital Stay ≥48 Hours

Treatments: Other: Plasma and urine I-FABP measurement

Study type: Observational

Funder types: Other

Identifiers

NCT07440368

I-FABP

Details and patient eligibility

About

Acute gastrointestinal injury (AGI) is a common but not fully understood organ dysfunction in critically ill patients. Current AGI grading systems rely primarily on clinical presentation and feeding tolerance, which are inherently subjective and may not accurately reflect the underlying biological severity of intestinal damage.

Intestinal fatty acid-binding protein (I-FABP) is a protein expressed almost exclusively in the cytoplasm of mature small intestinal epithelial cells. In cases of ischemia, inflammation, or mechanical injury, I-FABP is rapidly released into the bloodstream and subsequently excreted in the urine. These characteristics make I-FABP a highly specific biomarker for intestinal epithelial cell injury and intestinal ischemia.

A prospective study combining paired blood and urine I-FABP measurements, standardized AGI assessment, and careful consideration of surgical status was conducted to elucidate the role of intestinal epithelial cell injury in acute gastrointestinal dysfunction.

Full description

This study is a prospective observational cohort study conducted in an adult intensive care unit. Biological samples and clinical data will be prospectively collected according to a pre-defined protocol, without any intervention other than standard treatment.

Primary objective: To prospectively assess the association between serum and urinary I-FABP levels and the severity of acute gastrointestinal injury in critically ill patients.

Secondary objectives: To investigate the relationship between serum and urinary I-FABP levels and clinical outcomes (including severe AGI and mortality); to explore whether the intestinal epithelial cell injury patterns reflected by serum and urinary I-FABP are associated with different sepsis subphenotypes; and to evaluate the impact of gastrointestinal surgery on I-FABP levels and its modifying effect on the association between I-FABP and AGI severity.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1、 Age ≥18 years.
• 2 、Admission to the ICU with an expected ICU stay ≥48 hours.
• 3 、Availability of paired plasma and urine samples within 24 hours of ICU admission.
• 4 、Feasible daily gastrointestinal function assessment to complete AGI grading (ESICM definition).

Exclusion criteria

• 1、 Pre-existing inflammatory bowel disease.
• 2 、Short bowel syndrome.
• 3、 Chronic intestinal failure requiring long-term parenteral nutrition.
• 4、 Pregnancy.
• 5 、Refusal or withdrawal of informed consent.

Trial design

500 participants in 1 patient group

Critically ill adults admitted to the ICU

Description:

Consecutive adult critically ill patients (≥18 years) admitted to the ICU will be enrolled if ICU stay is expected to be ≥48 hours. Eligible participants must have paired plasma and urine samples obtainable within 24 hours of ICU admission and be able to undergo daily gastrointestinal function assessment for AGI grading. Exclusion criteria: pre-existing inflammatory bowel disease or short bowel syndrome; chronic intestinal failure requiring long-term parenteral nutrition; pregnancy; refusal or withdrawal of informed consent. Exposure of interest is plasma and urine intestinal fatty acid-binding protein (I-FABP) concentrations measured within 24 hours of ICU admission (continuous variables). Paired plasma and urine are collected within 24 hours and repeated on ICU day 3.

Treatment:

Other: Plasma and urine I-FABP measurement