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

Recruiting

• Conditions: alle aandoeningen met een Intensive Care indicatie; Enteral Nutrition; Intensive Care

• Registration Number: NL-OMON51811
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

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

• 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 <= 8)
• Suspected or confirmed pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are the 24-h rhythm in core body temperature at day 3 of<br /><br>the study period, assessed by amplitude and acrophase of cosinor fits</p><br>

Secondary Outcome Measures

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