Actively Recruiting
Study on the Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients
Led by Ruijin Hospital · Updated on 2026-04-09
500
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the relationship between gastrointestinal blood flow and the occurrence of enteral nutrition intolerance (ENI) and its symptoms in critically ill patients. It focuses on building and comparing predictive models that include blood flow parameters to better understand and predict ENI. The study is observational and conducted at Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, using machine learning to evaluate the added value of blood flow measurements. The study involves bedside ultrasound exams at four key times: when patients enter the ICU, and on Days 1, 4, and 7 of receiving enteral nutrition. These ultrasounds measure blood flow and vessel parameters in major abdominal vessels like the celiac artery, superior mesenteric artery, inferior vena cava, hepatic vein, and portal vein. Researchers will compare three predictive models: one based on clinical signs, another on blood flow data, and a combined model. Participants will be closely monitored daily from Day 1 to Day 7 of enteral nutrition for signs of intolerance and gastrointestinal symptoms. The study also tracks feeding success, ICU length of stay, and 28-day survival. Ultrasound assessments and clinical data collection help measure the primary outcome of ENI incidence, with safety and progress followed throughout the ICU stay, up to 28 days after admission.
CONDITIONS
Brief Title
Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Expected duration of enteral nutrition support longer than 7 days
- Patients or their legal representatives sign the informed consent form
You will not qualify if you...
- History of major gastrointestinal surgery such as subtotal gastrectomy and gastrointestinal anastomosis
- Contraindications to abdominal point-of-care ultrasound such as recent large-area abdominal burns, dressings blocking movement, or open abdomen
- Severe gastrointestinal diseases including gastroparesis, intestinal obstruction, digestive tract perforation, and gastrointestinal bleeding upon admission
- Severe peripheral vascular disease or valvular heart disease
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants undergoing enteral nutrition receive ultrasound evaluations of gastrointestinal blood flow and clinical assessments to monitor enteral nutrition intolerance and gastrointestinal symptoms.
4 ultrasound assessments: upon ICU admission, Day 1, Day 4, and Day 7 of enteral nutrition; daily clinical assessments from Day 1 to Day 7
Duration - Up to 28 days
Participants are observed for length of ICU stay and survival status up to 28 days post-ICU admission.
Ongoing observation until ICU discharge or Day 28 post-ICU admission
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
W
Weiqing Zhang, Ph.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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