A Prospective, Single-Center Observational Cohort Study of Feeding Intolerance in Critically Ill Patients: The JLU_Nutr_FI Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 主要终点
- Incidence of Feeding Intolerance Within 7 Days of ICU Admission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Feeding Intolerance Within 7 Days of ICU Admission
时间窗: 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.
次要结局
- 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)
- Health-Related Quality of Life at Day 90 Assessed Using the EQ-5D-5L Index(Day 90 after ICU admission)
- Health-Related Quality of Life at Day 180 Assessed Using the EQ-5D-5L Index(Day 180 after ICU admission)