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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Glycaemic variability [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days.]

Вторичные конечные точки (12)

• Glycaemic control [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days]
• Insulin administred during intervention period [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days]
• Dysglycemic events during intervention period [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days]
• Gastrointestinal tolerance during the intervention period [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days.]
• Gastrointestinal tolerance during the intervention period [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days]
• Circadian rhythm [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days.]
• Non-nutritonal calories administred during intervention period [Срок оценки: From enrollment to the end of the intervention at a maximum of 5 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 5 центров

• Gelderse Vallei Hospital — Ede
• Deventer Ziekenhuis — Deventer
• Medisch Spectrum Twente — Enschede
• Martini Ziekenhuis — Groningen
• Haga Ziekenhuis — The Hague

Идентификаторы

NCT: NCT07173504 · NL88158.091.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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