JLU_Nutr_FI Registry: A Prospective Registry of Feeding Intolerance in Critically Ill Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From ICU admission until day 7, ICU discharge, or death, whichever occurs firstSecondary outcomes
1
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.
Time frame
From ICU admission through day 282
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.
Time frame
From ICU admission through day 283
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.
Time frame
From ICU admission through day 284
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.
Time frame
From ICU admission through day 90Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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