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
Patients aged ≥ 18 years.
Patients expected to require enteral nutrition (EN) for ≥ 7 days.
Critically ill, mechanically ventilated patients in the ICU.
New patients initiating EN in the critical care unit.
Active GI bleeding.
Progressive GI disease.
Recent GI tract resection.
Indication for a special diet formula.
Parallel
20-Hour Cycled Enteral Nutrition with a 4-Hour Fasting Window
Behavioral20-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.
18-Hour Cycled Enteral Nutrition with a 6-Hour Fasting Window
BehavioralFeeding 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.
ICU Length of Stay (LOS)
The total number of days a patient spends in the intensive care unit, calculated from the date of ICU admission to the date of discharge or transfer out of the ICU.
Nosocomial Infection/Pneumonia Incidence
Infections acquired after 48 hours of hospital admission, specifically including Ventilator-Associated Pneumonia (VAP). Diagnosed based on CDC criteria (clinical signs, laboratory findings, and imaging).
Nutritional Adequacy
The percentage of the prescribed daily caloric goal that is actually delivered to the patient.
Gastrointestinal Complications
Adverse events related to feeding intolerance.
Gastric Emptying Index
A measure of gastrointestinal motility, indicated by delayed gastric emptying. Aspirate gastric contents via a nasogastric (NG) or orogastric (OG) tube at regular intervals (every 4 hours). gastric residual volume ≤ 500 mL, persistently high GRV (\>500 mL) indicates delayed emptying.
Inflammatory Marker
Level of systemic inflammation by Inflammatory Markers (e.g., CRP)
Patient Tolerance
The ability to receive enteral nutrition without significant adverse effects.
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This trial is not recruiting at the moment. You can still explore other options:
