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Not Yet Recruiting NCT07844538

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

Conditions: Critical Illness, Feeding Intolerance

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 2000
Sponsor: The First Hospital of Jilin University

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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years. 2. Admission to the intensive care unit (ICU). 3. Enrollment within 24 hours after ICU admission. 4. Enteral nutrition is planned or initiated during the ICU stay, allowing prospective assessment of feeding tolerance. 5. Written informed consent is obtained from the participant or an authorized representative. Exclusion Criteria: 1. Presence of an absolute contraindication to enteral nutrition at enrollment. 2. Expected withdrawal of life-sustaining treatment or imminent death at the time of screening. 3. Inability to complete the prespecified baseline assessments within 24 hours after ICU admission. 4. Previous enrollment in this study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07844538). StuddyBuddy aggregates publicly available trial information.