Optimizing Enteral Nutrition Regimen for Critically Ill Patients

NCT07270939 | Not Yet Recruiting

• 1 other identifier: MRC-01-25-949
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

Cyclic feeding; Feeding window; Critical care nutrition; Gastrointestinal tolerance; Nutritional adequacy

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Secondary Outcomes (11)

• 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.

Other Outcomes (2)

• Inflammatory Marker

  Measured daily from Day 1 to Day 7.The baseline value is recorded on Day 0.

• Patient Tolerance

  Measured daily from Day 1 to Day 7

Study Arms (3)

24-hour continuous feeding (control)

NO INTERVENTION

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.

20-hour cycled feeding (intervention)

ACTIVE COMPARATOR

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.

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

18-hour cycled feeding (intervention)

ACTIVE COMPARATOR

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.

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

Interventions

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

Also known as: Group Intervention 1

20-hour cycled feeding (intervention)

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

Also known as: Group Intervention 2

18-hour cycled feeding (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet ALL of the following criteria to be eligible for the study:
• 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.
• Patients receiving EN via:
• a nasogastric (NG) tube.
• orogastric (OG) feeding tube.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

MeSH Terms

Conditions

Critical Illness; Pneumonia, Ventilator-Associated; Hyperglycemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charge Nurse

Model Details: Interventional Study Model: Parallel Assignment. Participants are randomized in a 1:1:1 ratio to one of three parallel groups (24-hour continuous feeding, 20-hour cycled feeding, 18-hour cycled feeding) and remain in their assigned group for the study duration.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: December 8, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share