个性化透析液温度（MyTEMP）的主要结局：一项基于注册登记、实用性、整群随机对照试验的原理与设计
Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial.
作者信息
Al-Jaishi Ahmed A, McIntyre Christopher W, Sontrop Jessica M, Dixon Stephanie N, Anderson Sierra, Bagga Amit, Benjamin Derek, Berry David, Blake Peter G, Chambers Laura, Chan Patricia C K, Delbrouck Nicole, Devereaux P J, Ferreira-Divino Luis F, Goluch Richard, Gregor Laura, Grimshaw Jeremy M, Hanson Garth, Iliescu Eduard, Jain Arsh K, Lok Charmaine E, Mustafa Reem A, Nathoo Bharat, Nesrallah Gihad E, Oliver Matthew J, Pandeya Sanjay, Parmar Malvinder S, Perkins David, Presseau Justin, Rabin Eli, Sasal Joanna, Shulman Tanya, Sood Manish M, Steele Andrew, Tam Paul, Tascona Daniel, Wadehra Davinder, Wald Ron, Walsh Michael, Watson Paul, Wodchis Walter, Zager Phillip, Zwarenstein Merrick, Garg Amit X
机构信息
London Health Sciences Centre, ON, Canada.
ICES, ON, Canada.
出版信息
Can J Kidney Health Dis. 2020 Feb 5;7:2054358119887988. doi: 10.1177/2054358119887988. eCollection 2020.
BACKGROUND
Small randomized trials demonstrated that a lower compared with higher dialysate temperature reduced the average drop in intradialytic blood pressure. Some observational studies demonstrated that a lower compared with higher dialysate temperature was associated with a lower risk of all-cause mortality and cardiovascular mortality. There is now the need for a large randomized trial that compares the effect of a low vs high dialysate temperature on major cardiovascular outcomes.
OBJECTIVE
The purpose of this study is to test the effect of outpatient hemodialysis centers randomized to (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol for 4 years on cardiovascular-related death and hospitalizations.
DESIGN
The design of the study is a pragmatic, registry-based, open-label, cluster randomized controlled trial.
SETTING
Hemodialysis centers in Ontario, Canada, were randomized on February 1, 2017, for a trial start date of April 3, 2017, and end date of March 31, 2021.
PARTICIPANTS
In total, 84 hemodialysis centers will care for approximately 15 500 patients and provide over 4 million dialysis sessions over a 4-year follow-up.
INTERVENTION
Hemodialysis centers were randomized (1:1) to provide (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol of 36.5°C. For the personalized protocol, nurses set the dialysate temperature between 0.5°C and 0.9°C below the patient's predialysis body temperature for each dialysis session, to a minimum dialysate temperature of 35.5°C.
PRIMARY OUTCOME
A composite of cardiovascular-related death or major cardiovascular-related hospitalization (a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) captured in Ontario health care administrative databases.
PLANNED PRIMARY ANALYSIS
The primary analysis will follow an intent-to-treat approach. The hazard ratio of time-to-first event will be estimated from a Cox model. Within-center correlation will be considered using a robust sandwich estimator. Observation time will be censored on the trial end date or when patients die from a noncardiovascular event.
TRIAL REGISTRATION
www.clinicaltrials.gov; identifier: NCT02628366.
背景
小型随机试验表明，与较高透析液温度相比，较低透析液温度可降低透析期间血压的平均降幅。一些观察性研究表明，与较高透析液温度相比，较低透析液温度与全因死亡率和心血管死亡率风险较低相关。现在需要进行一项大型随机试验，比较低透析液温度与高透析液温度对主要心血管结局的影响。
目的
本研究的目的是测试门诊血液透析中心随机分配至（1）个性化降低温度的透析液方案或（2）标准温度透析液方案4年对心血管相关死亡和住院的影响。
设计
本研究的设计是一项基于登记的实用、开放标签、整群随机对照试验。
地点
加拿大安大略省的血液透析中心于2017年2月1日随机分组，试验开始日期为2017年4月3日，结束日期为2021年3月31日。
参与者
总共84个血液透析中心将在4年的随访中照顾约15500名患者，并提供超过400万次透析治疗。
干预措施
血液透析中心被随机分配（1:1）以提供（1）个性化降低温度的透析液方案或（2）36.5°C的标准温度透析液方案。对于个性化方案，护士在每次透析治疗时将透析液温度设定在低于患者透析前体温0.5°C至0.9°C之间，最低透析液温度为35.5°C。
主要结局
安大略省医疗保健管理数据库中记录的心血管相关死亡或主要心血管相关住院（因心肌梗死、充血性心力衰竭或缺血性中风入院）的综合情况。
计划的主要分析
主要分析将采用意向性分析方法。首次事件发生时间的风险比将通过Cox模型估计。将使用稳健三明治估计量考虑中心内相关性。观察时间将在试验结束日期或患者死于非心血管事件时进行截尾。
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