JLU_Nutr_FI Registry: A Prospective Registry of Feeding Intolerance in Critically Ill Patients
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.
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Feeding Intolerance Within 7 Days of ICU Admission
기간: 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. |
From ICU admission until day 7, ICU discharge, or death, whichever occurs first
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ICU-Free Days Through Day 28
기간: From ICU admission 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. |
From ICU admission through day 28
|
|
Invasive Ventilator-Free Days Through Day 28
기간: From ICU admission 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. |
From ICU admission through day 28
|
|
28-Day All-Cause Mortality
기간: From ICU admission through day 28
|
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. |
From ICU admission through day 28
|
|
90-Day All-Cause Mortality
기간: From ICU admission through day 90
|
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. |
From ICU admission through day 90
|
|
180-Day All-Cause Mortality
기간: From ICU admission through day 180
|
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. |
From ICU admission through day 180
|
|
Health-Related Quality of Life at Day 90 Assessed Using the EQ-5D-5L Index
기간: Day 90 after ICU admission
|
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. |
Day 90 after ICU admission
|
|
Health-Related Quality of Life at Day 180 Assessed Using the EQ-5D-5L Index
기간: Day 180 after ICU admission
|
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. |
Day 180 after ICU admission
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .