Optimizing Enteral Nutrition Regimen for Critically Ill Patients

NCT ID: NCT07270939

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-11-30

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.

Conditions

Critical Illness; Enteral Nutrition; Ventilator Associated Pneumonia; Hyperglycemia; Feeding Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

24-hour continuous feeding (control)

Feeding Schedule provides continuous enteral nutrition over 24 hours with no fasting window. This standard care in many ICUs serves as the baseline for comparison with two experimental cycled feeding regimens. The feeding rate is designed to evenly deliver the total daily caloric goal across the entire period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

20-hour cycled feeding (intervention)

Feeding Schedule consists of enteral nutrition delivered over 20 hours, with a structured 4-hour fasting window each day. This approach aims to balance metabolic and gastrointestinal benefits while ensuring adequate daily caloric intake. Consequently, the feeding rate is increased to meet the total caloric goal within the shorter feeding period.

Group Type: ACTIVE_COMPARATOR

20-Hour Cycled Enteral Nutrition with a 4-Hour Fasting Window

Intervention Type: BEHAVIORAL

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.

18-hour cycled feeding (intervention)

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.

Group Type: ACTIVE_COMPARATOR

18-Hour Cycled Enteral Nutrition with a 6-Hour Fasting Window

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Group Intervention 1; Group Intervention 2

Eligibility Criteria

Inclusion Criteria

Participants must meet ALL of the following criteria to be eligible for the study:

1. Patients aged ≥ 18 years.

2. Patients expected to require enteral nutrition (EN) for ≥ 7 days.

3. Critically ill, mechanically ventilated patients in the ICU.

4. New patients initiating EN in the critical care unit.

5. Patients receiving EN via:

• a nasogastric (NG) tube.
• orogastric (OG) feeding tube.

Exclusion Criteria

1. Patients with contraindications to enteral feeding or pre-existing gastrointestinal disorders, including:

• Active GI bleeding.
• Progressive GI disease.
• Recent GI tract resection.

2. Indication for a special diet formula.

3. Need for a large volume of feeding (as determined by the clinical team).

4. Pre-existing hepatic failure.

5. Use of a nasojejunal tube, gastrostomy, or jejunostomy.

6. Pregnancy confirmed via β-hCG testing for women of childbearing potential.

7. Insulin-dependent diabetes mellitus.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Mr.Mutaz Ibrahim Omar Othman

Charge Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MRC-01-25-949

Identifier Type: -

Identifier Source: org_study_id