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临床试验/NCT07521111
NCT07521111招募中不适用

Study on the Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Incidence of Enteral Nutrition Intolerance

研究概览

简要总结

This study aims to explore the correlation between gastrointestinal blood flow and the incidence of enteral nutrition intolerance (ENI) and its symptoms in critically ill patients, construct and compare predictive models including blood flow parameters, and evaluate their incremental predictive value.

详细描述

Enteral nutrition (EN) is the preferred route of nutritional support for critically ill patients. However, the occurrence of enteral nutrition intolerance (ENI) often limits its efficacy and interrupts nutritional supply. Current clinical assessment methods and existing predictive models for ENI mostly rely on subjective or delayed indicators. Normal gastrointestinal function is highly dependent on adequate blood perfusion and unobstructed venous return , but current research pays insufficient attention to the status of gastrointestinal blood flow. Point-of-care ultrasound (POCUS), due to its dynamic and visual nature, can be used to objectively evaluate these gastrointestinal indicators.

This study is designed as a prospective observational cohort study involving Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine. Researchers will perform bedside ultrasound evaluations at four specific time points: upon ICU admission, and on Day 1, Day 4, and Day 7 of enteral nutrition. The ultrasound assessments will measure various hemodynamic parameters including diameter, time-averaged maximum velocity, blood flow, and VExUS scores of major vessels such as the celiac artery (CA), superior mesenteric artery (SMA), inferior vena cava (IVC), hepatic vein (HV), and portal vein (PV).

The ultimate goal of this study is to employ machine learning algorithms to construct and compare three predictive models: a clinical indicator model, a blood flow parameter model, and a combined clinical-blood flow model. By doing so, the study will explore the independent predictive value of gastrointestinal blood flow for ENI and its symptoms in critically ill patients, evaluate the incremental value of adding blood flow parameters to the prediction models, and validate the models using an external dataset.

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

入选标准

  • Age > 18 years old.
  • Expected duration of enteral nutrition support > 7 days.
  • Patients or their legal representatives sign the informed consent form.

排除标准

  • History of major gastrointestinal surgery such as subtotal gastrectomy and gastrointestinal anastomosis.
  • Contraindications to abdominal point-of-care ultrasound (POCUS) examination (e.g., recent large-area abdominal burns, dressings blocking movement, open abdomen).
  • Presence of severe gastrointestinal diseases such as gastroparesis, intestinal obstruction, digestive tract perforation, and gastrointestinal bleeding upon admission.
  • Presence of severe peripheral vascular disease or valvular heart disease.
  • Pregnant or lactating women.

研究组 & 干预措施

Critically ill patients

Eligible ICU patients from Ruijin Hospital are receiving enteral nutrition.

结局指标

主要结局

Incidence of Enteral Nutrition Intolerance

时间窗: Assessed daily from Day 1 to Day 7 of enteral nutrition

The rate of enteral nutrition intolerance occurs during the first 7 days of enteral nutrition support.

次要结局

  • Incidence of gastrointestinal symptoms(Assessed daily from Day 1 to Day 7 of enteral nutrition)
  • Achievement rate of targeted feeding volume(Assessed daily from Day 1 to Day 7 of enteral nutrition)
  • Length of ICU stay(Until ICU discharge, up to 28 days)
  • 28-day mortality rate(up to day 28 post-ICU admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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