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

Mass General Brigham

Status: Enrolling

Conditions: Glucose Intolerance; Sleep; Feeding Patterns

Treatments: Dietary Supplement: Time-of-day of enteral nutrition provision (daytime first); Dietary Supplement: Time-of-day of enteral nutrition provision (nighttime first)

Study type: Interventional

Funder types: Other

Identifiers

NCT04737200

2020P003989

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Nighttime cycled enteral feeds first

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Time-of-day of enteral nutrition provision (nighttime first)

Daytime cycled enteral feeds first

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Time-of-day of enteral nutrition provision (daytime first)