NCT05795881

Effect of Continuous Versus Cyclic Daytime Enteral Nutrition on Circadian Rhythms in Critical Illness

Effect of Continuous Versus Cyclic Daytime Enteral Nutrition on Circadian Rhythms in Critical Illness: CIRCLES Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Disruption of circadian rhythms is frequently observed in patients in the intensive care unit (ICU) and is associated with worse clinical outcomes. The ICU environment presents weak and conflicting timing cues to the circadian clock, including continuous enteral nutrition. The goal of this clinical trial is to evaluate the effect of timing of enteral nutrition on the circadian rhythm in critically ill patients. Patients admitted to the intensive care unit will be allocated to receive either continuous or cyclic daytime (8am to 8 pm) enteral feeding. Differences in circadian rhythms will be assessed by 24h patterns in core body temperature, heart rate variability, melatonin and peripheral clock gene expression. Secondary outcomes include depth of sleep, glucose variability and incidence of feeding intolerance. This study is expected to contribute to the optimalisation of circadian rhythms in the ICU.

Conditions

• Critical Illness
• Intensive Care Unit
• Circadian Rhythm
• Sleep
• Enteral Nutrition

Interventions

Type	Name	Description
OTHER	Cyclic daytime enteral nutrition	The allocated feeding schedule is followed from the start of enteral nutrition after ICU admission until discharge from the ICU.

Timeline

• Start date: 2023-06-14
• Primary completion: 2025-03-15
• Completion: 2025-03-15
• First posted: 2023-04-03
• Last updated: 2025-03-20

Locations

1 site across 1 country: Netherlands