Clinical trial NCT04737200: The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Official title: The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Feeding Patterns
Sleep
Glucose Intolerance
Keywords: Enteral Nutrition
Chrononutrition
Intensive Care Unit
Chronobiology
Nutrition Support
Sleep
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sleep fragmentation
timeFrame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
measure: Circadian rhythms amplitude
timeFrame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary outcomes:
measure: Sleep arousals
timeFrame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
measure: Total sleep time
timeFrame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
measure: Duration of sleep stages
timeFrame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
measure: Sleep midpoint
timeFrame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
measure: Acrophase
timeFrame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
measure: Midpoint of least-active 5h timing
timeFrame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
measure: Midpoint of most-active 10h timing
timeFrame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
measure: Inactivity duration
timeFrame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
measure: 12 hours average systolic and diastolic blood pressure
timeFrame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
measure: 12 hours average glucose
timeFrame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
measure: C-reactive protein
timeFrame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
measure: Interleukin-6
timeFrame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
measure: Tumor necrosis factor α
timeFrame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hassan S Dashti, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dashti HS, Wang YM, Knauert MP. Feeding critically ill patients at the right time of day. Crit Care. 2024 Jun 24;28(1):206. doi: 10.1186/s13054-024-04994-0. No abstract available.