JLU_Nutr_FI Registry: A Prospective Registry of Feeding Intolerance in Critically Ill Patients

NCT07844538 | Not Yet Recruiting DMC

• 1 other identifier: JLU_Nutr_FI
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Feeding Intolerance; Critical Illness

Keywords

Feeding intolerance; Enteral nutrition; Critical illness; Intensive care unit; Gastrointestinal dysfunction; Gastric ultrasound; Electrogastrography; Risk prediction

Outcome Measures

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.

  From ICU admission until day 7, ICU discharge, or death, whichever occurs first

Secondary Outcomes (7)

• ICU-Free Days Through Day 28

  From ICU admission through day 28

• Invasive Ventilator-Free Days Through Day 28

  From ICU admission through day 28

• 28-Day All-Cause Mortality

  From ICU admission through day 28

• 90-Day All-Cause Mortality

  From ICU admission through day 90

• 180-Day All-Cause Mortality

  From ICU admission through day 180

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected within 24 hours after ICU admission. Serum and/or plasma specimens are processed and stored for planned and future analyses of biomarkers related to gastrointestinal function, inflammation, nutritional and metabolic status, and feeding intolerance. No genetic or DNA-based analyses are planned.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09