Correlation Study Between SMA Blood Flow Reactivity and Acute Gastrointestinal Injury in Critically Ill Patients

NCT07001943 | Recruiting

• 1 other identifier: SMART(SMA Reactivity Trial)
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to address the challenges of enteral nutrition support in critically ill ICU patients with varying gastrointestinal function. We'll use bedside Doppler ultrasound to monitor superior mesenteric artery (SMA) blood flow changes post - feeding, exploring its correlation with Acute Gastrointestinal Injury (AGI) and other hemodynamic indicators. Our goals are to identify the patterns of SMA blood flow changes, establish a predictive model linking SMA blood flow reactivity to AGI risk, and propose individualized enteral nutrition strategies based on intestinal hemodynamics. Through this innovative approach, we hope to enhance the safety of enteral nutrition, reduce AGI incidence, and improve patient outcomes.

Conditions

Intestinal Ischemia; Critical Illness; Enteral Nutrition Feeding; Hemodynamics; Ultrasonography, Doppler

Keywords

Enteral Nutrition; Critical Illness; Intestinal Ischemia; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• feeding intolerance

  the incidence of feeding intolerance, defined as the frequency of feeding interruptions or reductions due to gastrointestinal complications like vomiting, gastric residuals, or abdominal distension during the study period.

  From enrollment to the end of treatment at 3 days

Interventions

enteral nutrition OTHER

We'll use an enteral nutrition intervention with intact protein formulations. Initiate nasogastric tube feeding at 20ml/h and continue for 24 hours. Adjust feeding strategies based on patients' SMA blood flow reactivity.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from adult patients admitted to the ICU. Participants will be those aged between 18 and 80 years old, with an expected ICU stay of more than 72 hours after enrolled, and who require the initiation of enteral nutrition support. These patients are at risk of gastrointestinal dysfunction and acute gastrointestinal injury (AGI), making them suitable candidates for a study focused on optimizing enteral nutrition strategies and monitoring gastrointestinal blood flow.

You may qualify if:

• Adults aged ≥18 years and ≤80 years.
• Admitted to the study with a expected stay of more than 72 hours.
• Require initiation of enteral nutrition support.

You may not qualify if:

• Pre-existing severe gastrointestinal diseases.
• Patients with gastrointestinal bleeding.
• Patients with bowel obstruction.
• Pregnant or lactating women.
• Patients with contraindications to bedside Doppler ultrasound.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)