Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:38 AM
Study NCT ID:
NCT07440368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and urine (paired with plasma). The first samples were collected within 24 hours of ICU admission; samples were repeated on day 3.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum AGI grade during ICU stay (ESICM 0-IV)', 'timeFrame': 'From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Severe AGI during ICU stay (AGI grade III-IV)', 'timeFrame': 'From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.', 'description': '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).'}, {'measure': '28-day all-cause mortality', 'timeFrame': 'Up to 28 days after ICU admission.', 'description': 'Death from any cause within 28 days after ICU admission.'}, {'measure': 'ICU length of stay', 'timeFrame': 'From ICU admission(Day 1) through ICU discharge or death, up to 28 days.', 'description': 'ICU length of stay, defined as the number of days from ICU admission to ICU discharge or death.'}, {'measure': 'Sepsis subphenotype characterized by an intestinal epithelial cell injury pattern', 'timeFrame': '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.', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intestinal Fatty Acid-Binding Protein', 'Acute Gastrointestinal Dysfunction', 'Critical Illness'], 'conditions': ['Patients Admitted to the ICU', 'Expected Hospital Stay ≥48 Hours', 'Adult']}, 'descriptionModule': {'briefSummary': '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.\n\nIntestinal 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.\n\nA 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.', 'detailedDescription': '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.\n\nPrimary objective: To prospectively assess the association between serum and urinary I-FABP levels and the severity of acute gastrointestinal injury in critically ill patients.\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1、 Age ≥18 years.\n* 2 、Admission to the ICU with an expected ICU stay ≥48 hours.\n* 3 、Availability of paired plasma and urine samples within 24 hours of ICU admission.\n* 4 、Feasible daily gastrointestinal function assessment to complete AGI grading (ESICM definition).\n\nExclusion Criteria:\n\n* 1、 Pre-existing inflammatory bowel disease.\n* 2 、Short bowel syndrome.\n* 3、 Chronic intestinal failure requiring long-term parenteral nutrition.\n* 4、 Pregnancy.\n* 5 、Refusal or withdrawal of informed consent.'}, 'identificationModule': {'nctId': 'NCT07440368', 'briefTitle': 'Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': '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）', 'orgStudyIdInfo': {'id': 'I-FABP'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Other: Plasma and urine I-FABP measurement']}], 'interventions': [{'name': 'Plasma and urine I-FABP measurement', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Critically ill adults admitted to the ICU']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yanhua Li', 'role': 'CONTACT', 'email': 'liyanhua@jlu.edu.cn', 'phone': '86-15804301738'}], 'overallOfficials': [{'name': 'Hongxiang Li', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared at this time due to privacy and regulatory considerations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}