Continuous versus daytime intermittent tube feeding for critically ill adults

The Effect of Continuous Versus Intermittent Enteral Nutrition on Metabolic Outcomes in Critically Ill Patients

This trial tests whether daytime intermittent tube feeding, given as four one-hour portions between 8 am and 8 pm, leads to better blood sugar control and metabolic outcomes than continuous 24-hour tube feeding in critically ill adults on or expected to need mechanical ventilation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gelderse Vallei Hospital (Academic / other)
• Locations: 5 sites (Ede, Gelderland and 4 other locations)
• Trial ID: NCT07173504 on ClinicalTrials.gov

What this trial studies

Critically ill adult patients who are receiving or eligible for exclusive gastric tube feeding will receive either continuous 24-hour enteral nutrition or a daytime intermittent feeding pattern (four one-hour portions between 08:00 and 20:00) for up to five days or until exclusive gastric feeding stops. The study will compare glycaemic control using continuous glucose monitoring, gastrointestinal function and hormones, markers of sleep quality and circadian rhythm, and changes in lean body mass and body composition. Common ICU exclusions such as pregnancy, burn injuries, expected prolonged fasting, readmission within 14 days, or participation in another nutrition trial apply. The trial is being run at three regional hospitals in the Netherlands with support from Wageningen University and ZonMw.

Who should consider this trial

Good fit: Adults (≥18 years) in the ICU who are receiving or eligible for exclusive gastric tube feeding, expected to remain in the ICU for at least 48 hours, and who are on or anticipated to require invasive mechanical ventilation within 48 hours are the intended participants.

Not a fit: Patients who are pregnant, have burn injuries, are expected to fast for ≥12 hours during the study period, cannot receive exclusive gastric tube feeding, or are judged to be imminently dying are unlikely to receive benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, this approach could improve blood sugar control, support gut function, and help preserve lean body mass in critically ill patients fed by tube.

How similar studies have performed: Previous small randomized and non-randomized studies comparing intermittent and continuous enteral feeding have produced mixed results for glycaemic control and clinical outcomes, and incorporating sleep and circadian markers in ICU nutrition research is relatively new.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years;
2. Receiving or eligible to receive exclusively gastric tube feeding;
3. Expected ICU stay ≥48 hours;
4. Receiving or anticipated to receive invasive mechanical ventilation within 48 hours after ICU admission.

Exclusion Criteria:

1. The treating clinician considers participation in the study clinically contraindicated (e.g., change in feeding regimen, no possibility for placement of CGM on arms, not able to receive exclusive gastric tube feeding);
2. Death is deemed to be imminent or inevitable during admission, and the attending doctor, patient, or substitute decision-maker is not committed to active treatment;
3. Pregnancy;
4. Expected fasting for ≥12 hours during the study period, for example, due to medical procedures;
5. Readmission in last 14 days;
6. Patients with burn injuries;
7. Participating in another nutritional intervention study.

Where this trial is running

Ede, Gelderland and 4 other locations

• Gelderse Vallei Hospital — Ede, Gelderland, Netherlands (Recruiting)
• Deventer Ziekenhuis — Deventer, Overijssel, Netherlands (Recruiting)
• Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (Recruiting)
• Martini Ziekenhuis — Groningen, Provincie Groningen, Netherlands (Recruiting)
• Haga Ziekenhuis — The Hague, South Holland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Arthur RH van Zanten

Conditions Critical Illness; critical illness; tube feeding; glycemic control; chrononutrition