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

Gelderse Vallei Hospital

Status: Enrolling

Conditions: Critical Illness

Treatments: Other: Intermittent enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT07173504

NL88158.091.24

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Continuous enteral nutrition

No Intervention group

Description:

Participants will receive the standard of care, continuous enteral nutrition for 24 hours a day.

Intermittent enteral nutrition

Experimental group

Description:

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.

Treatment:

Other: Intermittent enteral nutrition