Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07521111

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

junjie hua

CONTACT

[email protected]

86 18175005982

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Enteral Nutrition Intolerance

    Time frame: 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

  1. Incidence of gastrointestinal symptoms

    Time frame: 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

  2. Achievement rate of targeted feeding volume

    Time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition

    The rate of achieving 80% of the target feeding volume

  3. Length of ICU stay

    Time frame: Until ICU discharge, up to 28 days

  4. 28-day mortality rate

    Time frame: up to day 28 post-ICU admission

Study contacts

Contact information is provided by the study sponsor or research team.

Weiqing Zhang, Ph.D

CONTACT

[email protected]

8618521525300

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.