The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Feeding Patterns Sleep Glucose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Time-of-day of enteral nutrition provision (nighttime first)

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.

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.

Group Type EXPERIMENTAL

Time-of-day of enteral nutrition provision (daytime first)

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.

Interventions

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Time-of-day of enteral nutrition provision (daytime first)

Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.

Intervention Type DIETARY_SUPPLEMENT

Time-of-day of enteral nutrition provision (nighttime first)

Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No