Optimizing Enteral Nutrition Regimen for Critically Ill Patients

Official title

Optimizing Enteral Nutrition: A Comparative Study of 18-Hour, 20-Hour, and 24-Hour

Overview

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.

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 r

Primary outcome measures

• 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).]

Secondary outcome measures (11)

• Nosocomial Infection/Pneumonia Incidence [Time frame: Assessed daily from Day 3 to Day 7.]
• Nutritional Adequacy [Time frame: Calculated daily from Day 1 to Day 7]
• Gastrointestinal Complications [Time frame: Monitored daily from Day 1 to Day 7]
• Gastric Emptying Index [Time frame: Measured every 4 hours, daily from Day 1 to Day 7.]
• Glycemic Control [Time frame: Daily, from Day 1 to Day 7 of the intervention.]
• Insulin Requirement [Time frame: Daily, from Day 1 to Day 7 of the intervention.]
• Serum Creatinine level, measured in mg/dL (or µmol/L) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: Measured daily from Day 1 to Day 7 of the intervention. The baseline value is recorded on Day 0.]

Eligibility criteria

Inclusion criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07270939 · MRC-01-25-949

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗