The goal of this clinical trial is to investigate the effect of continuous versus intermittent enteral nutrition on metabolic outcomes in critically ill adult patients.
The aim of this study is to:
• To assess the effect of a daytime intermittent tube feeding pattern compared to standard continuous tube feeding on glycaemic control, gastrointestinal function, gastrointestinal hormones, markers of sleep quality and circadian rhythm, and lean body mass and body composition.
Participants will receive either continuous enteral nutrition for 24 hours a day or intermittent enteral nutrition during the day, consisting of 4 portions each administered over 1 hour between 8 am and 8 pm. The maximum duration of the intervention is 5 days or until participants do not receive exclusive gastric enteral nutrition.
Age ≥18 years;
Receiving or eligible to receive exclusively gastric tube feeding;
Expected ICU stay ≥48 hours;
Receiving or anticipated to receive invasive mechanical ventilation within 48 hours after ICU admission.
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);
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;
Pregnancy;
Expected fasting for ≥12 hours during the study period, for example, due to medical procedures;
Parallel
Intermittent enteral nutrition
Other interventionParticipants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period.
Glycaemic variability
The primary outcome is the mean glycaemic variability per 24 hours during the intervention, measured with Continuous Glucose Monitoring (CGM), expressed as the Coefficient of Variation (COV). The COV is calculated by dividing the standard deviation by the mean blood glucose level and multiplying by 100. It gives a relative measure of variability, which is helpful in comparing variability between individuals or groups with different mean glucose levels.
Glycaemic control
Assessed by mean and standard deviation of interstitial glucose concentrations and Mean Amplitude of Glycaemic Excursions (MAGE) (mmol/L)
Insulin administred during intervention period
Insulin administred during intervention period (IU/day)
Dysglycemic events during intervention period
Number of hypoglycaemic events, defined as blood glucose level \<4.0 mmol/L and number of hyperglycaemic events, defined as blood glucose level \>10.0 mmol/L
Gastrointestinal tolerance during the intervention period
Gastric residual volumes (mL), minimum, maximum and total volume per 24 hours.
ICU length of stay
ICU length of stay
Days on mechanical ventilation
Days on mechanical ventilation
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Gelderse Vallei Hospital
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Wageningen University and Research
Collaborator
