The Effect of Continuous Versus Intermittent Enteral Nutrition on Metabolic Outcomes in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent enteral nutrition.
- Who it may be relevant to
- Registry conditions: Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Intermittent enteral nutrition
Participants 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.
Primary outcome measures
- Glycaemic variability [Time frame: From enrollment to the end of the intervention at a maximum of 5 days.]
Secondary outcome measures (12)
- Glycaemic control [Time frame: From enrollment to the end of the intervention at a maximum of 5 days]
- Insulin administred during intervention period [Time frame: From enrollment to the end of the intervention at a maximum of 5 days]
- Dysglycemic events during intervention period [Time frame: From enrollment to the end of the intervention at a maximum of 5 days]
- Gastrointestinal tolerance during the intervention period [Time frame: From enrollment to the end of the intervention at a maximum of 5 days.]
- Gastrointestinal tolerance during the intervention period [Time frame: From enrollment to the end of the intervention at a maximum of 5 days]
- Circadian rhythm [Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.]
- Circadian rhythm [Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.]
- Circadian rhythm [Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.]
- Body composition [Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.]
- Muscle size [Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.]
- Nutritional intake during intervention period [Time frame: From enrollment to the end of the intervention at a maximum of 5 days.]
- Non-nutritonal calories administred during intervention period [Time frame: From enrollment to the end of the intervention at a maximum of 5 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Readmission in last 14 days;
- Patients with burn injuries;
- Participating in another nutritional intervention study.
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
Netherlands · 5 centers
- Gelderse Vallei Hospital — Ede
- Deventer Ziekenhuis — Deventer
- Medisch Spectrum Twente — Enschede
- Martini Ziekenhuis — Groningen
- Haga Ziekenhuis — The Hague
Identifiers
NCT: NCT07173504 · NL88158.091.24