The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Circadian rhythms amplitude
研究概览
简要总结
The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, preserves circadian rhythms, and improves overall inflammation and cardiometabolic profiles in postoperative patients in the cardiac surgical ICU on enteral nutrition.
详细描述
Intensive care unit (ICU) environments do not support sleep or preserve circadian rhythms of postoperative critically ill patients. Among the contributing factors is the common practice of administering nutrition support through feeding tubes overnight. The overall objective of the study is to examine a novel dimension of clinical nutrition by determining whether enhancing sleep quality and preserving robust circadian rhythms through daytime instead of overnight feeds will attenuate inflammation and improve cardiometabolic profiles of postoperative cardiac ICU patients on nutrition support. The investigators hypothesize that overnight nutrition support results in fragmented sleep and blunted circadian rhythms and thus represent a modifiable mechanism exacerbating inflammation and cardiometabolic derangements in postoperative cardiac patients. Results of this study will help in the development of evidence-based, cost-efficient, and effective enteral nutrition timing countermeasures against fragmented sleep, disrupted circadian rhythms, inflammation and cardiometabolic derangements and potentially modify the current widespread practice of overnight nutrition likely affecting 250,000 hospital admissions annually in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Adult male or non-pregnant female volunteers (age 18+)
- •Scheduled for a cardiac surgical procedure with planned post-operative admission to the ICU for >48 hours
- •Able and willing to give consent and comply with study procedures
排除标准
- •Blind, deaf or unable to speak English
- •Women who are pregnant or nursing
- •Contraindications to safe use enteral nutrition, including gastrointestinal obstruction
- •Personal history of intestinal malabsorption, gallbladder disease or pancreatitis
- •Dietary restrictions precluding enteral feeds
- •Renal and liver failure requiring dialysis or Child-Pugh score > 7
- •Severe deficit due to structural or anoxic brain damage
- •With skin condition that precludes wearing sensors
研究组 & 干预措施
Nighttime cycled enteral feeds first
Patients will start nighttime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start daytime cycled enteral feeds for 12 hours.
干预措施: Time-of-day of enteral nutrition provision (nighttime first) (Dietary Supplement)
Daytime cycled enteral feeds first
Patients will start daytime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start nighttime cycled enteral feeds for 12 hours.
干预措施: Time-of-day of enteral nutrition provision (daytime first) (Dietary Supplement)
结局指标
主要结局
Circadian rhythms amplitude
时间窗: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Amplitude is defined as peak-to-nadir difference in rhythms estimated from body temperature and actigraphy.
Sleep fragmentation
时间窗: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Sleep fragmentation is defined as the number of shifts from deeper (N2, N3, REM) to lighter (W or N1) sleep stages by hours of sleep. Sleep fragmentation will be assessed objectively through EEG measures.
次要结局
- Duration of sleep stages(Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.)
- C-reactive protein(Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.)
- Tumor necrosis factor α(Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.)
- Sleep arousals(Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.)
- Sleep midpoint(Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.)
- Acrophase(Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.)
- Total sleep time(Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.)
- Midpoint of least-active 5h timing(Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.)
- Midpoint of most-active 10h timing(Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.)
- Inactivity duration(Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.)
- 12 hours average systolic and diastolic blood pressure(Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.)
- 12 hours average glucose(Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.)
- Interleukin-6(Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.)
研究者
Hassan Dashti
Principal Investigator
Massachusetts General Hospital