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Clinical Trial NCT07440368 for Patients Admitted to the ICU, Expected Hospital Stay ≥48 Hours, Adult is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness 500 Biomarker-Driven
Clinical Trial NCT07440368 is an observational study for Patients Admitted to the ICU, Expected Hospital Stay ≥48 Hours, Adult and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 500 participants. Led by The First Hospital of Jilin University, this study is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 27 February 2026.
Brief Summary
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 ...
Show MoreDetailed 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 critica...
Show MoreOfficial 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）
Conditions
Patients Admitted to the ICUExpected Hospital Stay ≥48 HoursAdultOther Study IDs
- I-FABP
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-02-27
Completion Date (Estimated)
2026-12-01
Enrollment (Estimated)
500
Study Type
Observational
Status
Not yet recruiting
Keywords
Intestinal Fatty Acid-Binding Protein
Acute Gastrointestinal Dysfunction
Critical Illness
Acute Gastrointestinal Dysfunction
Critical Illness
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Critically ill adults admitted to the ICU 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 inte...Show More | Plasma and urine I-FABP measurement 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 Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days. |
28-day all-cause mortality | Death from any cause within 28 days after ICU admission. | Up to 28 days after ICU admission. |
ICU length of stay | ICU length of stay, defined as the number of days from ICU admission to ICU discharge or death. | From ICU admission(Day 1) through ICU discharge or death, up to 28 days. |
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). | 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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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).
- 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.
The First Hospital of Jilin UniversityStudy Central Contact
Contact: Yanhua Li, 86-15804301738, [email protected]
No location data.