Optimizing Enteral Nutrition Regimen for Critically Ill Patients
NCT07270939 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-12-08
Summary
Clinical Trial The goal of this clinical trial is to learn whether different enteral feeding cycles (18-hour, 20-hour, or standard 24-hour continuous feeding) improve outcomes for critically ill ICU patients who need tube feeding. It will also look at tolerance, nutrition delivery, and safety.
The main questions it aims to answer are:
Do shorter feeding cycles (with fasting windows) reduce ICU length of stay?
Do they lower the risk of infections like ventilator-associated pneumonia?
How do they affect calorie delivery, blood sugar control, and gastrointestinal tolerance?
Researchers will compare:
Continuous 24-hour feeding (standard care)
20-hour feeding with a 4-hour fasting window
18-hour feeding with a 6-hour fasting window
Participants will:
Be critically ill adults in the ICU who require at least 7 days of enteral feeding
Be randomized to one of the three feeding schedules
Receive daily monitoring of calories, protein, blood sugar, and GI tolerance
Have outcomes measured, including ICU length of stay, infections, metabolic control, and feeding tolerance
Conditions
- Critical Illness
- Enteral Nutrition
- Ventilator Associated Pneumonia
- Hyperglycemia
- Feeding Intolerance
Interventions
- BEHAVIORAL
-
20-Hour Cycled Enteral Nutrition with a 4-Hour Fasting Window
20-Hour Cycled Enteral Nutrition with a 4-Hour Fasting Window (Intervention 1) Objective: To evaluate the physiological benefits of a structured daily fasting period while maintaining a conservative approach to caloric delivery.
- BEHAVIORAL
-
18-Hour Cycled Enteral Nutrition with a 6-Hour Fasting Window
Feeding Schedule involves enteral nutrition over an 18-hour period while incorporating a 6-hour fasting window in each 24-hour cycle. This structure is designed to test a more intense intermittent fasting regimen, aiming to enhance physiological benefits by better aligning with circadian rhythms. The expectations include improved metabolic control, enhanced gastrointestinal motility, and reduced infection rates, with careful monitoring for reduced caloric intake risk. Consequently, the feeding rate is increased to meet daily caloric goals within the 18-hour timeframe, resulting in the most intensive feeding schedule among the three examined arms.
Sponsors & Collaborators
-
Hamad Medical Corporation
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-30
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
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