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

Study on the 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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Machine Learning; Prediction Models; Enteral Nutrition Feeding; Enteral Nutrition Intolerance

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Weiqing Zhang, Ph.D; Phone Number: 8618521525300; Email: weiq.zh@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: junjie hua; Phone Number: 86 18175005982; Email: junjie.hua615@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients admitted to the Intensive Care Units (ICUs) of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. These patients require continuous enteral nutrition support with an expected duration of more than 7 days.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Critically ill patients; Eligible ICU patients from Ruijin Hospital are receiving enteral nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Enteral Nutrition Intolerance	The rate of enteral nutrition intolerance occurs during the first 7 days of enteral nutrition support.	Assessed daily from Day 1 to Day 7 of enteral nutrition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of gastrointestinal symptoms	The rate of gastrointestinal symptoms, including reflux, vomiting, aspiration, diarrhea, delayed gastric emptying, and abdominal distension	Assessed daily from Day 1 to Day 7 of enteral nutrition
Achievement rate of targeted feeding volume	The rate of achieving 80% of the target 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

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: ZWQ-2026-GIBF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No