循环日间与连续肠内营养对危重病患者昼夜节律的影响（CIRCLES）：一项随机对照试验的研究方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-04-27 DOI:10.1016/j.cct.2025.107927

Floor W. Hiemstra , Marit F. van Gent , Evert de Jonge , David J. van Westerloo , Laura Kervezee

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引用次数: 0

摘要

重症监护病房（ICU）危重患者的昼夜节律和睡眠经常被打乱，这与临床结果不佳有关。进食-禁食周期作为昼夜节律系统的同步提示，表明在ICU中优化这些周期可以加强昼夜节律。CIRCLES试验评估与持续肠内营养相比，循环日间肠内营养是否能改善危重患者的24小时节律。目的描述CIRCLES研究的研究方案。研究设计CIRCLES研究是一项在荷兰三级护理ICU进行的研究者发起的随机对照试验。入住ICU且预计住院时间≥48小时且接受或打算开始肠内营养治疗的患者（年龄≥18岁）符合纳入条件。60例患者随机分为连续肠内营养组（全天营养）和日间循环肠内营养组（08:00 ~ 20:00 h营养）。主要结果测量主要结果是24小时核心体温节律的振幅。次要结局包括24小时心率节律、平均血压心率变异性、褪黑激素和基因表达、葡萄糖调节、胰岛素给药、热量摄入和喂养不耐受。我们假设，与连续喂养相比，日间循环喂养策略会导致生命体征、心率变异性和褪黑素的24小时节律幅度更高，从而表明昼夜节律强度有所提高。本研究旨在为优化ICU患者昼夜节律的策略提供见解。试验注册：2023年4月在ClinicalTrials.gov注册（NCT05795881）。

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Effect of cyclic daytime versus continuous enteral nutrition on circadian rhythms in critical illness (CIRCLES): Study protocol for a randomized controlled trial

Background

Circadian rhythms and sleep are often disrupted in critically ill patients in the intensive care unit (ICU), which has been linked to poor clinical outcomes. Feeding-fasting cycles serve as a synchronizing cue for the circadian timing system, indicating that optimizing these cycles in the ICU could reinforce circadian rhythms. The CIRCLES trial evaluates whether cyclic daytime enteral nutrition improves 24-h rhythms in critically ill patients compared to continuous enteral nutrition.

Objective

To describe the study protocol for the CIRCLES study.

Study design

The CIRCLES study is an investigator-initiated randomized controlled trial in a tertiary care ICU in the Netherlands. Patients (aged ≥18 years) admitted to the ICU with an expected stay ≥48 h receiving or with intention to start enteral nutrition are eligible for inclusion. Patients (n = 60) are randomized to the continuous enteral nutrition (nutrition around the clock) or cyclic daytime enteral nutrition group (nutrition between 08:00 h to 20:00 h).

Main outcome measures

The primary outcome is the amplitude of 24-h rhythms in core body temperature. Secondary outcomes include 24-h rhythms in heart rate, mean blood pressure heart rate variability, melatonin and gene expression, glucose regulation, insulin administration, caloric intake and feeding intolerance.

Conclusion

We hypothesize that a cyclic daytime feeding strategy will result in a higher amplitude of 24-h rhythms in vital signs, heart rate variability, and melatonin, compared to continuous feeding, thereby suggesting improved circadian rhythm strength. This study aims to provide insight into strategies to optimize circadian rhythms in ICU patients.

Trial registration

Registered at ClinicalTrials.gov (NCT05795881), April 2023.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.