Critical IllnessNCT07844538
JLU_Nutr_FI Registry: A Prospective Registry of Feeding Intolerance in Critically Ill Patients
An observational study of Critical Illness and Feeding Intolerance, run by The First Hospital of Jilin University.
Trial summary
This prospective observational cohort study aims to characterize feeding intolerance in critically ill adult patients and to identify clinical, physiological, laboratory, electrophysiological, and imaging factors associated with its development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Feeding Intolerance
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2029
- How long will I take part?
- 180 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: The study population consists of adult critically ill patients admitted to the participating intensive care unit(s). Eligible participants are enrolled prospectively within 24 hours after ICU admission and undergo standardized early multimodal assessment, including blood sampling, gastrointestinal electrophysiological assessment, gastric antral ultrasonography, skeletal muscle ultrasonography, intra-abdominal pressure measurement, and collection of relevant clinical and laboratory data. Participants are subsequently followed for feeding intolerance and short- and long-term clinical outcomes.
Who may be able to join
- Age ≥18 years.
- Admission to the intensive care unit (ICU).
- Enrollment within 24 hours after ICU admission.
- Enteral nutrition is planned or initiated during the ICU stay, allowing prospective assessment of feeding tolerance.
- Written informed consent is obtained from the participant or an authorized representative.
Who cannot join
- Presence of an absolute contraindication to enteral nutrition at enrollment.
- Expected withdrawal of life-sustaining treatment or imminent death at the time of screening.
- Inability to complete the prespecified baseline assessments within 24 hours after ICU admission.
- Previous enrollment in this study.
About this study
Official title: A Prospective, Single-Center Observational Cohort Study of Feeding Intolerance in Critically Ill Patients: The JLU_Nutr_FI Registry
This prospective observational cohort study aims to characterize feeding intolerance in critically ill adult patients and to identify clinical, physiological, laboratory, electrophysiological, and imaging factors associated with its development.
Within 24 hours after intensive care unit (ICU) admission, participants undergo systematic multimodal assessment, including blood sampling, gastrointestinal electrophysiological measurements, gastric antral ultrasonography with assessment of antral motility, skeletal muscle ultrasonography, intra-abdominal pressure measurement, and collection of relevant clinical and laboratory variables.
Read more
Participants are prospectively followed for the occurrence of feeding intolerance and other clinically relevant outcomes. The study will evaluate the incidence, predictors, and risk factors of feeding intolerance and explore whether multimodal measurements obtained within the first 24 hours after ICU admission can improve early prediction of feeding intolerance compared with conventional clinical variables.
Additional outcomes include duration of organ support, ICU-free days, ventilator-free days, mortality at 28, 90, and 180 days, and longer-term health-related quality of life assessed using the EQ-5D-5L.
The overall objective is to improve understanding of feeding intolerance in critically ill patients, enable early risk stratification, and provide a theoretical basis for future individualized nutritional assessment and management strategies.
Read the detailed description
Feeding intolerance is common among critically ill patients receiving enteral nutrition and may contribute to inadequate nutrient delivery, prolonged organ support, and unfavorable clinical outcomes. However, feeding intolerance is heterogeneous and may reflect alterations in gastrointestinal motility, gastrointestinal perfusion and function, systemic inflammation, severity of illness, intra-abdominal pressure, metabolic disturbances, and other patient-specific factors. Reliable methods for early identification of patients at high risk of feeding intolerance remain limited.
JLU_nutr is a prospective observational cohort study designed to systematically characterize feeding intolerance in critically ill adult patients. No study-specific therapeutic intervention is assigned, and clinical treatment and nutritional support are provided according to routine clinical practice and the judgment of the treating clinical team.
Within 24 hours after ICU admission, participants undergo a standardized multidimensional assessment. This includes collection of blood samples; gastrointestinal electrophysiological measurements; gastric antral ultrasonography, including assessment of antral size and motility; skeletal muscle ultrasonography; measurement of intra-abdominal pressure; and collection of relevant demographic, clinical, physiological, laboratory, nutritional, and severity-of-illness variables.
Participants are prospectively monitored for the development of feeding intolerance according to prespecified study criteria. Information on enteral nutrition delivery, gastrointestinal manifestations, organ support, and other relevant clinical variables is collected longitudinally during the ICU stay.
The study will investigate the incidence and clinical characteristics of feeding intolerance and examine associations between variables obtained within the first 24 hours after ICU admission and subsequent feeding intolerance. Candidate predictors include demographic and clinical characteristics, severity of illness, laboratory biomarkers, gastrointestinal electrophysiological parameters, gastric ultrasonography-derived measures, skeletal muscle ultrasonography-derived measures, intra-abdominal pressure, and other prospectively collected variables.
A major objective of the study is to develop and evaluate approaches for early prediction and risk stratification of feeding intolerance using conventional clinical variables alone and in combination with multimodal measurements obtained within the first 24 hours after ICU admission. The incremental predictive value of physiological, laboratory, electrophysiological, and imaging-derived variables will also be explored.
Participants are additionally followed for clinically important short- and long-term outcomes, including duration of organ support, ICU-free days, ventilator-free days, ICU and hospital outcomes, all-cause mortality at 28, 90, and 180 days, and health-related quality of life assessed using the EQ-5D-5L.
Because this is an observational study, analyses are intended to evaluate associations, prediction, and risk stratification rather than to establish causal effects of individual exposures. The study is expected to provide a multidimensional characterization of feeding intolerance in critical illness and to generate evidence supporting future individualized nutritional assessment and intervention studies.
- Conditions
- Critical Illness, Feeding Intolerance
- Keywords
- Feeding intolerance, Enteral nutrition, Critical illness, Intensive care unit, Gastrointestinal dysfunction, Gastric ultrasound, Electrogastrography, Risk prediction
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Feeding Intolerance Within 7 Days of ICU Admission
Proportion of participants experiencing at least one episode of feeding intolerance during the first 7 days after intensive care unit (ICU) admission. Feeding intolerance is defined as [insert the complete protocol-specified diagnostic criteria, including relevant thresholds]. Feeding tolerance is assessed daily until day 7, ICU discharge, or death, whichever occurs first. The date of the first qualifying episode and the individual components of feeding intolerance are recorded.
Measured: From ICU admission until day 7, ICU discharge, or death, whichever occurs first
Secondary outcomes (7)
ICU-Free Days Through Day 28
Number of days alive and outside an intensive care unit during the first 28 days after ICU admission. Participants who die within 28 days are assigned 0 ICU-free days. All ICU stays, including readmissions, are included in the calculation.
Measured: From ICU admission through day 28
Invasive Ventilator-Free Days Through Day 28
Number of days alive and free from invasive mechanical ventilation during the first 28 days after ICU admission. Participants who die within 28 days are assigned 0 ventilator-free days. All periods of invasive mechanical ventilation, including reintubation, are included in the calculation.
Measured: From ICU admission through day 28
28-Day All-Cause Mortality
Proportion of participants who die from any cause within 28 days after ICU admission. Vital status is ascertained from medical records and follow-up contact with participants or their families.
Measured: From ICU admission through day 28
90-Day All-Cause Mortality
Proportion of participants who die from any cause within 90 days after ICU admission. Vital status is ascertained from medical records and follow-up contact with participants or their families.
Measured: From ICU admission through day 90
180-Day All-Cause Mortality
Proportion of participants who die from any cause within 180 days after ICU admission. Vital status is ascertained from medical records and follow-up contact with participants or their families.
Measured: From ICU admission through day 180
Health-Related Quality of Life at Day 90 Assessed Using the EQ-5D-5L Index
Health-related quality of life among participants alive at day 90, assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Health states are converted into an index score using the Chinese EQ-5D-5L value set published in 2017. Index scores range from -0.391 to 1, with higher scores indicating better health-related quality of life.
Measured: Day 90 after ICU admission
Health-Related Quality of Life at Day 180 Assessed Using the EQ-5D-5L Index
Health-related quality of life among participants alive at day 180, assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Health states are converted into an index score using the Chinese EQ-5D-5L value set published in 2017. Index scores range from -0.391 to 1, with higher scores indicating better health-related quality of life.
Measured: Day 180 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- 2,000 participants (estimated)
- Target duration
- 180 Days
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844538
- Sponsor's protocol ID
- JLU_Nutr_FI
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center Observational Cohort Study of Feeding Intolerance in Critically Ill Patients: The JLU_Nutr_FI Registry
- ClinicalTrials.gov ID
- NCT07844538
- Acronym / sponsor ID
- JLU_Nutr_FI
- Conditions
- Critical Illness, Feeding Intolerance
- Keywords
- Feeding intolerance, Enteral nutrition, Critical illness, Intensive care unit, Gastrointestinal dysfunction, Gastric ultrasound, Electrogastrography, Risk prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Sep 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.
This prospective observational cohort study aims to characterize feeding intolerance in critically ill adult patients and to identify clinical, physiological, laboratory, electrophysiological, and imaging factors associated with its development.
Within 24 hours after intensive care unit (ICU) admission, participants undergo systematic multimodal assessment, including blood sampling, gastrointestinal electrophysiological measurements, gastric antral ultrasonography with assessment of antral motility, skeletal muscle ultrasonography, intra-abdominal pressure measurement, and collection of relevant clinical and laboratory variables.
Participants are prospectively followed for the occurrence of feeding intolerance and other clinically relevant outcomes. The study will evaluate the incidence, predictors, and risk factors of feeding intolerance and explore whether multimodal measurements obtained within the first 24 hours after ICU admission can improve early prediction of feeding intolerance compared with conventional clinical variables.
Additional outcomes include duration of organ support, ICU-free days, ventilator-free days, mortality at 28, 90, and 180 days, and longer-term health-related quality of life assessed using the EQ-5D-5L.
The overall objective is to improve understanding of feeding intolerance in critically ill patients, enable early risk stratification, and provide a theoretical basis for future individualized nutritional assessment and management strategies.
Detailed description
Feeding intolerance is common among critically ill patients receiving enteral nutrition and may contribute to inadequate nutrient delivery, prolonged organ support, and unfavorable clinical outcomes. However, feeding intolerance is heterogeneous and may reflect alterations in gastrointestinal motility, gastrointestinal perfusion and function, systemic inflammation, severity of illness, intra-abdominal pressure, metabolic disturbances, and other patient-specific factors. Reliable methods for early identification of patients at high risk of feeding intolerance remain limited.
JLU_nutr is a prospective observational cohort study designed to systematically characterize feeding intolerance in critically ill adult patients. No study-specific therapeutic intervention is assigned, and clinical treatment and nutritional support are provided according to routine clinical practice and the judgment of the treating clinical team.
Within 24 hours after ICU admission, participants undergo a standardized multidimensional assessment. This includes collection of blood samples; gastrointestinal electrophysiological measurements; gastric antral ultrasonography, including assessment of antral size and motility; skeletal muscle ultrasonography; measurement of intra-abdominal pressure; and collection of relevant demographic, clinical, physiological, laboratory, nutritional, and severity-of-illness variables.
Participants are prospectively monitored for the development of feeding intolerance according to prespecified study criteria. Information on enteral nutrition delivery, gastrointestinal manifestations, organ support, and other relevant clinical variables is collected longitudinally during the ICU stay.
The study will investigate the incidence and clinical characteristics of feeding intolerance and examine associations between variables obtained within the first 24 hours after ICU admission and subsequent feeding intolerance. Candidate predictors include demographic and clinical characteristics, severity of illness, laboratory biomarkers, gastrointestinal electrophysiological parameters, gastric ultrasonography-derived measures, skeletal muscle ultrasonography-derived measures, intra-abdominal pressure, and other prospectively collected variables.
A major objective of the study is to develop and evaluate approaches for early prediction and risk stratification of feeding intolerance using conventional clinical variables alone and in combination with multimodal measurements obtained within the first 24 hours after ICU admission. The incremental predictive value of physiological, laboratory, electrophysiological, and imaging-derived variables will also be explored.
Participants are additionally followed for clinically important short- and long-term outcomes, including duration of organ support, ICU-free days, ventilator-free days, ICU and hospital outcomes, all-cause mortality at 28, 90, and 180 days, and health-related quality of life assessed using the EQ-5D-5L.
Because this is an observational study, analyses are intended to evaluate associations, prediction, and risk stratification rather than to establish causal effects of individual exposures. The study is expected to provide a multidimensional characterization of feeding intolerance in critical illness and to generate evidence supporting future individualized nutritional assessment and intervention studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 180 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult critically ill patients admitted to the participating intensive care unit(s). Eligible participants are enrolled prospectively within 24 hours after ICU admission and undergo standardized early multimodal assessment, including blood sampling, gastrointestinal electrophysiological assessment, gastric antral ultrasonography, skeletal muscle ultrasonography, intra-abdominal pressure measurement, and collection of relevant clinical and laboratory data. Participants are subsequently followed for feeding intolerance and short- and long-term clinical outcomes.
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Admission to the intensive care unit (ICU).
- Enrollment within 24 hours after ICU admission.
- Enteral nutrition is planned or initiated during the ICU stay, allowing prospective assessment of feeding tolerance.
- Written informed consent is obtained from the participant or an authorized representative.
Key exclusion criteria (4 listed)
- Presence of an absolute contraindication to enteral nutrition at enrollment.
- Expected withdrawal of life-sustaining treatment or imminent death at the time of screening.
- Inability to complete the prespecified baseline assessments within 24 hours after ICU admission.
- Previous enrollment in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Feeding Intolerance Within 7 Days of ICU Admission
Time frame: From ICU admission until day 7, ICU discharge, or death, whichever occurs first
Proportion of participants experiencing at least one episode of feeding intolerance during the first 7 days after intensive care unit (ICU) admission. Feeding intolerance is defined as [insert the complete protocol-specified diagnostic criteria, including relevant thresholds]. Feeding tolerance is assessed daily until day 7, ICU discharge, or death, whichever occurs first. The date of the first qualifying episode and the individual components of feeding intolerance are recorded.
7 secondary outcomes
ICU-Free Days Through Day 28
Time frame: From ICU admission through day 28
Invasive Ventilator-Free Days Through Day 28
Time frame: From ICU admission through day 28
28-Day All-Cause Mortality
Time frame: From ICU admission through day 28
90-Day All-Cause Mortality
Time frame: From ICU admission through day 90
180-Day All-Cause Mortality
Time frame: From ICU admission through day 180
Health-Related Quality of Life at Day 90 Assessed Using the EQ-5D-5L Index
Time frame: Day 90 after ICU admission
Health-Related Quality of Life at Day 180 Assessed Using the EQ-5D-5L Index
Time frame: Day 180 after ICU admission
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 28 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Feeding Intolerance, 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 5 inclusion and 4 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 28 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Feeding Intolerance Within 7 Days of ICU Admission (time frame: From ICU admission until day 7, ICU discharge, or death, whichever occurs first). 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 28 Sep 2026.