The primary objective is to evaluate whether cyclic daytime enteral feeding can decrease the disruption of circadian rhythms in critically ill patients compared to continuous enteral feeding. Secondary objectives are to evaluate the effect of cyclic…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
alle aandoeningen met een Intensive Care indicatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Patients in the intensive care unit (ICU) are subjected to an environment
presenting weak and conflicting timing cues to the circadian clock, including
continuous enteral feeding. Multiple lines of evidence show that circadian
rhythms and sleep/wake cycles are severely disrupted in critically ill patients
and that this contributes to worse clinical outcomes. Rhythmic feeding-fasting
cycles provide a potent synchronizing cue for the circadian clock and can
restore dampened circadian rhythms in physiological and metabolic processes.
Study objective
The primary objective is to evaluate whether cyclic daytime enteral feeding can
decrease the disruption of circadian rhythms in critically ill patients
compared to continuous enteral feeding. Secondary objectives are to evaluate
the effect of cyclic feeding on depth of sleep, glucose dysregulation, insulin
administration, feeding intolerance and clinical outcomes.
Study design
Investigator-initiated randomized-controlled trial
Intervention
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 daytime, between 8.00h to 20.00h.
Patient in the *continuous feeding* group will receive continuous enteral
feeding over 24 hours. Standard of care protocols with regard to daily
nutritional goals, initiation scheme, treatment of gastric retention and
glucose regulation are followed for both groups and are thus equal between
them.
Study burden and risks
Potential risks for the patient in the cyclic daytime feeding group are
gastrointestinal intolerance, potentially leading to lower caloric intake, and
glucose dysregulation. However, increased dosing rates of enteral nutrition
have repeatedly been shown to be safe, effective and feasible. Nevertheless,
the glucose regulation and gastric retention protocols will be closely followed
to minimize the risks. No risks are related to the additional measurements
performed on the study subjects (electro-encephalography and blood sampling).
Potential benefits for study participants is the close monitoring of glucose
levels and gastric retention. The study is group-related as it investigates the
effects of daytime feeding on the circadian rhythm in the critically ill
patients population.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL81929.058.22 |