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NCT Number: NCT07440368

Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness

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.

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Key information

Conditions

Patients Admitted to the ICU Adult Critical Illness Disease Attributes Expected Hospital Stay ≥48 Hours Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma and urine I-FABP measurement

Other

Paired plasma and urine samples will be collected within 24 hours of ICU admission to quantify intestinal fatty acid-binding protein (I-FABP) concentrations (continuous measures) using a standardized laboratory assay. A second paired sampling will be performed on ICU day 3 to assess changes over time. No therapeutic intervention is assigned; this study is observational.

Primary outcomes

  1. Maximum AGI grade during ICU stay (ESICM 0-IV)

    Time frame: From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.

    AGI severity will be assessed daily during ICU stay and graded as an ordinal outcome (0, I, II, III, IV) according to the ESICM Working Group definition. The primary outcome is the maximum (worst) AGI grade observed from ICU admission (Day 1) through ICU discharge or death, up to 28 days. Effect modification by gastrointestinal surgery will be explored using an interaction term.

Secondary outcomes

  1. Severe AGI during ICU stay (AGI grade III-IV)

    Time frame: From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.

    AGI severity will be assessed daily during ICU stay and graded (0, I, II, III, IV) according to the ESICM Working Group definition. Severe AGI is defined as any occurrence of AGI grade III or IV during the assessment period and will be reported as a binary outcome (yes/no).

  2. 28-day all-cause mortality

    Time frame: Up to 28 days after ICU admission.

    Death from any cause within 28 days after ICU admission.

  3. ICU length of stay

    Time frame: From ICU admission(Day 1) through ICU discharge or death, up to 28 days.

    ICU length of stay, defined as the number of days from ICU admission to ICU discharge or death.

  4. Sepsis subphenotype characterized by an intestinal epithelial cell injury pattern

    Time frame: Within 24 hours of ICU admission and ICU day 3 (for classification), with outcomes assessed during ICU stay and/or up to day 28 as applicable.

    A biomarker-defined sepsis subphenotype characterized by an intestinal epithelial cell injury pattern will be identified according to a prespecified definition/algorithm based on I-FABP profiles (plasma and urine) measured within 24 hours of ICU admission and on ICU day 3 (categorical classification).

Study contacts

Contact information is provided by the study sponsor or research team.

Yanhua Li

CONTACT

[email protected]

86-15804301738

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness: A Prospective Observational Study of Blood and Urinary Intestinal Fatty Acid-Binding Protein(Implications for Sepsis Heterogeneity）

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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