NCT07521111

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Jun 2027

Study Start

First participant enrolled

January 25, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 9, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Critically ill patients

Eligible ICU patients from Ruijin Hospital are receiving enteral nutrition.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Weiqing Zhang, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

January 25, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations