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Effect of cyclic versus continuous enteral nutrition on circadian rhythms in critical illness: the CIRCLES study

Effect of cyclic versus continuous enteral nutrition on circadian rhythms in critical illness: the CIRCLES study - CIRCLES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51811
Enrollment
60
Registered
2022-12-09
Start date
2023-06-19
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alle aandoeningen met een Intensive Care indicatie Enteral Nutrition Intensive Care

Interventions

Patients will be allocated to either the *cyclic feeding* or *continuous feeding* group. Patients in the *cyclic feeding* group will receive continuous enteral feeding in a 12 hour period during day

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: • Receiving parenteral nutrition • Oral intake • Prior night-time (20.00h - 8.00h) enteral or parenteral nutrition 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 • Treatment with extracorporeal membrane oxygenation • Severe neurological damage (significant neurological abnormalities such as bleeding, ischemia, neurotrauma or severe encephalopathy with Glasgow Coma Scale

Design outcomes

Primary

MeasureTime frame
Main study parameters are the 24-h rhythm in core body temperature at day 3 of the study period, assessed by amplitude and acrophase of cosinor fits

Secondary

MeasureTime frame
Secondary study parameters are the difference between daytime and night-time melatonin levels at day 3 of the study period, 24-h rhythms in systolic blood pressure, heart rate and heart rate variability, 24-hour rhythms in circulating metabolites, peripheral clock gene expression, depth of sleep, mean daily rate of hyperglycaemia/hypoglycaemia, mean daily glucose variability, mean daily insulin administration, compliance to study protocol, mean daily caloric intake, daily rates of gastric residual volume > 200 mL, 28-day mortality, days on mechanical ventilation and ICU length of stay

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)