Effect of Continuous Versus Cyclic Daytime Enteral Nutrition on Circadian Rhythms in Critical Illness: CIRCLES Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Amplitude of 24-h rhythm of core body temperature
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Amplitude of 24-h rhythm of core body temperature
时间窗: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Determined by cosinor analysis
Acrophase 24-h rhythm of core body temperature
时间窗: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Determined by cosinor analysis
次要结局
- Acrophase of 24-h rhythm in heart rate(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Days on mechanical ventilation(From ICU admission to ICU discharge)
- ICU length of stay(From ICU admission to ICU discharge)
- Daily rates of gastric retention(From start of study intervention (enteral nutrition) to end of study intervention)
- Acrophase of 24-h rhythm in heart rate variability(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Amplitude of 24-h rhythm in systolic blood pressure(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Amplitude of 24-h rhythm in heart rate(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Amplitude of 24-h rhythm of plasma melatonin levels(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Acrophase of 24-h rhythm of plasma melatonin levels(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Peripheral clock gene expression(Day 3 (12 p.m.) to day 4 (12 a.m.) after start of the study intervention (= start of enteral nutrition))
- Mean daily rate of hyperglycaemia/hypoglycaemia(From start of study intervention (enteral nutrition) to end of study intervention)
- Mean daily glucose variability(From start of study intervention (enteral nutrition) to end of study intervention)
- Mean daily insulin administration(From start of study intervention (enteral nutrition) to end of study intervention)
- Mean daily caloric intake(From start of study intervention (enteral nutrition) to end of study intervention)
- Amplitude of 24-h rhythm in heart rate variability(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Acrophase of 24-h rhythm in systolic blood pressure(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- Depth of sleep(Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition))
- 28-day mortality(Up to 28 days)
研究者
David van westerloo
MD PhD
Leiden University Medical Center