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

NCT07521111 — Recruiting, 500 participants, Ruijin Hospital

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

RegistryNCT07521111
StatusRecruiting
Study typeObservational
Enrollment500 (Estimated)
SponsorRuijin Hospital (Other)
ConditionsCritical Illness, Enteral Nutrition Intolerance, Enteral Nutrition Feeding, Prediction Models, Machine Learning
Datesstart 2026-01-25, primary completion 2026-12-31 (estimated), completion 2027-06-30 (estimated), first posted 2026-04-09, last updated 2026-04-09
Locations1 site in China

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-Summary

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Critically ill patientsEligible ICU patients from Ruijin Hospital are receiving enteral nutrition.

+Outcome measures

Primary outcomes

  • Incidence of Enteral Nutrition Intolerance [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.

Secondary outcomes

  • Incidence of gastrointestinal symptoms [Assessed daily from Day 1 to Day 7 of enteral nutrition]: The rate of gastrointestinal symptoms, including reflux, vomiting, aspiration, diarrhea, delayed gastric emptying, and abdominal distension
  • Achievement rate of targeted feeding volume [Assessed daily from Day 1 to Day 7 of enteral nutrition]: The rate of achieving 80% of the target feeding volume
  • Length of ICU stay [Until ICU discharge, up to 28 days]
  • 28-day mortality rate [up to day 28 post-ICU admission]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghaiChinaRecruiting

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