Patients Admitted to the ICUNCT07440368
Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness
An observational study of Patients Admitted to the ICU and Expected Hospital Stay ≥48 Hours, run by The First Hospital of Jilin University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Admitted to the ICU, Expected Hospital Stay ≥48 Hours, Adult
- What is being tested?
- Plasma and urine I-FABP measurement
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Dec 2026
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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）
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.
Read the detailed 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.
- Being tested
- Plasma and urine I-FABP measurement
- Keywords
- Intestinal Fatty Acid-Binding Protein, Acute Gastrointestinal Dysfunction, Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma and urine I-FABP measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 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. Receives: Other: Plasma and urine I-FABP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Admitted to the ICUStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongxiang Li, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440368
- Sponsor's protocol ID
- I-FABP
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared at this time due to privacy and regulatory considerations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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）
- ClinicalTrials.gov ID
- NCT07440368
- Acronym / sponsor ID
- I-FABP
- Keywords
- Intestinal Fatty Acid-Binding Protein, Acute Gastrointestinal Dysfunction, Critical Illness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill adults admitted to the ICU | – | Other: Plasma and urine I-FABP measurementConsecutive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma and urine I-FABP measurementPaired 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. | Other | Critically ill adults admitted to the ICU |
Primary outcome
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.
4 secondary outcomes
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.
28-day all-cause mortality
Time frame: Up to 28 days after ICU admission.
ICU length of stay
Time frame: From ICU admission(Day 1) through ICU discharge or death, up to 28 days.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared at this time due to privacy and regulatory considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongxiang Li study chair
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Admitted to the ICU and Expected Hospital Stay ≥48 Hours, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanhua Li (86-15804301738, liyanhua@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.