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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous enteral nutrition

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Intermittent enteral nutrition

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Intermittent tube feeding

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No