Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
1、 Pre-existing inflammatory bowel disease.
2 、Short bowel syndrome.
3、 Chronic intestinal failure requiring long-term parenteral nutrition.
4、 Pregnancy.
Trial population
This prospective observational cohort will consecutively enroll adult critically ill patients (≥18 years) admitted to the ICU with an expected ICU stay of at least 48 hours. Paired plasma and urine samples will be collected within 24 hours of ICU admission (and repeated on ICU day 3) to measure intestinal fatty acid-binding protein (I-FABP). Gastrointestinal function will be assessed daily during ICU stay to grade acute gastrointestinal injury (AGI) according to the ESICM definition. Patients with pre-existing inflammatory bowel disease, short bowel syndrome, chronic intestinal failure requiring long-term parenteral nutrition, pregnancy, or those who refuse/withdraw consent will be excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Plasma and urine I-FABP measurement
Other interventionPaired 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Critically ill adults admitted to the ICU1 intervention
Trial outcomes
Primary outcomes
1
Maximum AGI grade during ICU stay (ESICM 0-IV)
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.
Time frame
From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.Secondary outcomes
1
Severe AGI during ICU stay (AGI grade III-IV)
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).
Time frame
From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.2
28-day all-cause mortality
Death from any cause within 28 days after ICU admission.
Time frame
Up to 28 days after ICU admission.3
ICU length of stay
ICU length of stay, defined as the number of days from ICU admission to ICU discharge or death.
Time frame
From ICU admission(Day 1) through ICU discharge or death, up to 28 days.4
Sepsis subphenotype characterized by an intestinal epithelial cell injury pattern
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).
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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