The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Time-of-day of enteral nutrition provision (daytime first), Time-of-day of enteral nutrition provision (nighttime first).
- Кому может быть актуально
- Состояния в реестре: Feeding Patterns, Sleep, Glucose Intolerance. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Пищевая добавка Time-of-day of enteral nutrition provision (daytime first)
Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime. - Пищевая добавка Time-of-day of enteral nutrition provision (nighttime first)
Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.
Первичные конечные точки
- Sleep fragmentation [Срок оценки: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Circadian rhythms amplitude [Срок оценки: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
Вторичные конечные точки (12)
- Sleep arousals [Срок оценки: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Total sleep time [Срок оценки: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Duration of sleep stages [Срок оценки: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Sleep midpoint [Срок оценки: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.]
- Acrophase [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
- Inactivity duration [Срок оценки: 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 [Срок оценки: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
- 12 hours average glucose [Срок оценки: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.]
- C-reactive protein [Срок оценки: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.]
- Interleukin-6 [Срок оценки: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Massachusetts General Hospital — Boston
Публикации
- 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
Идентификаторы
NCT: NCT04737200 · 2020P003989