An observational study in Critical Illness and Feeding Intolerance, sponsored by The First Hospital of Jilin University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by The First Hospital of Jilin University · Observational
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.
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.
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.
Exclusion Criteria:
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 first
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 180 after ICU admission
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The First Hospital of Jilin University