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

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Circadian Rhythm

Enteral Nutrition

Critical Illness

Intensive Care Unit

Sleep

Treatments

Other: Cyclic daytime enteral nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT05795881

P22.080

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years old
Receiving of or intention to start enteral nutrition via nasogastric or nasoduodenal tube
Arterial line
Expected duration of ICU admission > 48 hours

Exclusion criteria

Receiving parenteral nutrition
Prior night-time (20.00h - 8.00h) enteral tube feeding within the same hospitalization before study inclusion
Readmission to ICU with prior study inclusion
Chronic enteral tube feeding prior to current admission
Presence of one or more contraindications of enteral feeding and/or at significant risk for gastrointestinal tolerance according to standard protocol (including but not limited to gastrointestinal haemorrhage, intestinal ischemia or necrosis, impaired digestive tract integrity due to obstruction or perforation, gastrectomy, enterectomy, history of gastroparesis or oesophageal dysmotility or expected surgery within 24 hours)
Patients with glycaemic emergency (including but not limited to hyperglycaemic hyperosmolar nonketotic coma, diabetic ketoacidosis, severe hypoglycaemia resulting in ICU admission) or patients controlling their glucose levels and insulin dosing via continuous glucose monitoring
Expected death within 24 hours
Do-not-resuscitate (DNR) order
Treatment with extracorporeal membrane oxygenation
Severe neurological damage (significant neurological abnormalities such as bleeding, ischemia, neurotrauma or severe encephalopathy with Glasgow Coma Scale ≤ 8)
Suspected or confirmed pregnancy