Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critical Illness, Enteral Nutrition Intolerance, Enteral Nutrition Feeding, Prediction Models. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients
Overview
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.
Detailed description
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.
Primary outcome measures
- Incidence of Enteral Nutrition Intolerance [Time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition]
Secondary outcome measures (4)
- Incidence of gastrointestinal symptoms [Time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition]
- Achievement rate of targeted feeding volume [Time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition]
- Length of ICU stay [Time frame: Until ICU discharge, up to 28 days]
- 28-day mortality rate [Time frame: up to day 28 post-ICU admission]
Eligibility criteria
Inclusion criteria
- Age > 18 years old.
- Expected duration of enteral nutrition support > 7 days.
- Patients or their legal representatives sign the informed consent form.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07521111 · ZWQ-2026-GIBF