Optimizing Enteral Nutrition: A Comparative Study of 18-Hour, 20-Hour, and 24-Hour
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hamad Medical Corporation
- Enrollment
- 150
- Primary Endpoint
- ICU Length of Stay (LOS)
Overview
Brief 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
Detailed Description
This randomized controlled trial will compare three enteral feeding regimens in critically ill ICU patients: standard 24-hour continuous feeding, 20-hour cycled feeding with a 4-hour fasting window, and 18-hour cycled feeding with a 6-hour fasting window. The rationale is that continuous feeding may impair metabolic regulation, increase insulin requirements, and contribute to gastrointestinal intolerance, while cycled feeding could better align with circadian rhythms, support metabolic balance, and reduce complications such as ventilator-associated pneumonia.
Approximately 150 adult patients who require enteral nutrition for at least seven days will be enrolled across Hamad Medical Corporation ICUs. Participants will be randomized in a 1:1:1 ratio using block randomization through REDCap to ensure allocation concealment. All groups will receive isocaloric enteral nutrition through nasogastric or orogastric tubes, with caloric and protein targets guided by indirect calorimetry or weight-based calculations.
Feeding plans will be initiated within 24 hours of ICU admission or stabilization. Patients assigned to the 18-hour and 20-hour arms will have structured fasting periods, while the control group will receive uninterrupted feeding. Daily assessments will capture nutritional delivery, gastrointestinal tolerance, and metabolic parameters, along with safety monitoring for adverse events. Data will be collected electronically via REDCap, de-identified, and audited regularly by the Clinical Trial Unit.
The study is designed to generate high-quality evidence on whether incorporating fasting windows into feeding schedules can optimize nutrition therapy, improve tolerance, reduce ICU stays, and minimize complications. Findings are expected to inform future ICU nutrition guidelines and contribute to the global discussion on intermittent versus continuous feeding practices.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Participants and clinical care teams will be aware of the assigned enteral feeding schedule. Outcome assessors and the statistician performing the final analysis will be blinded to group allocation where feasible.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients with contraindications to enteral feeding or pre-existing gastrointestinal disorders, including:
- •Active GI bleeding.
- •Progressive GI disease.
- •Recent GI tract resection.
- •Indication for a special diet formula.
- •Need for a large volume of feeding (as determined by the clinical team).
- •Pre-existing hepatic failure.
- •Use of a nasojejunal tube, gastrostomy, or jejunostomy.
- •Pregnancy confirmed via β-hCG testing for women of childbearing potential.
- •Insulin-dependent diabetes mellitus.
Outcomes
Primary Outcomes
ICU Length of Stay (LOS)
Time Frame: From the date of randomization until the date of ICU discharge or transfer, assessed up to 90 days (or until hospital discharge if it occurs earlier).
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.
Secondary Outcomes
- Nosocomial Infection/Pneumonia Incidence(Assessed daily from Day 3 to Day 7.)
- Nutritional Adequacy(Calculated daily from Day 1 to Day 7)
- Gastrointestinal Complications(Monitored daily from Day 1 to Day 7)
- Gastric Emptying Index(Measured every 4 hours, daily from Day 1 to Day 7.)
- Glycemic Control(Daily, from Day 1 to Day 7 of the intervention.)
- Insulin Requirement(Daily, from Day 1 to Day 7 of the intervention.)
- Serum Creatinine level, measured in mg/dL (or µmol/L)(Measured daily from Day 1 to Day 7. The baseline value is recorded on Day 0.)
- Blood Urea Nitrogen (BUN) level, measured in mg/dL (or mmol/L)(Measured daily from Day 1 to Day 7 of the intervention. The baseline value is recorded on Day 0.)
- Alanine Aminotransferase (ALT) level, measured in U/L(Measured daily from Day 1 to Day 7 of the intervention. The baseline value is recorded on Day 0.)
- Aspartate Aminotransferase (AST) level, measured in U/L(Measured daily from Day 1 to Day 7 of the intervention. The baseline value is recorded on Day 0.)
- Total Bilirubin level, measured in mg/dL (or µmol/L)(Measured daily from Day 1 to Day 7 of the intervention. The baseline value is recorded on Day 0.)
Investigators
Mr.Mutaz Ibrahim Omar Othman
Charge Nurse
Hamad Medical Corporation