The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-of-day of enteral nutrition provision (daytime first), Time-of-day of enteral nutrition provision (nighttime first).
- Who it may be relevant to
- Registry conditions: Feeding Patterns, Sleep, Glucose Intolerance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Time-of-day of enteral nutrition provision (daytime first)
Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime. - Dietary supplement Time-of-day of enteral nutrition provision (nighttime first)
Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.
Primary outcome measures
- Sleep fragmentation [Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Circadian rhythms amplitude [Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
Secondary outcome measures (12)
- Sleep arousals [Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Total sleep time [Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Duration of sleep stages [Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Sleep midpoint [Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Acrophase [Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
- Midpoint of least-active 5h timing [Time frame: 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 [Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
- Inactivity duration [Time frame: 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 [Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
- 12 hours average glucose [Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
- C-reactive protein [Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.]
- Interleukin-6 [Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Publications
- 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. PMID 38915028
- Luetz A, Spies C, Kervezee L. It's about time: circadian medicine in the intensive care unit. Intensive Care Med. 2024 Feb;50(2):283-286. doi: 10.1007/s00134-023-07297-0. Epub 2023 Dec 19. No abstract available. PMID 38112772
Identifiers
NCT: NCT04737200 · 2020P003989