The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration
The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration
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DOI：
10.1681/asn.2018090945
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发表时间：
2019-05-01
影响因子：
13.6
通讯作者：
Landis, J. Richard
中科院分区：
文献类型：
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作者：
Dember, Laura M.;Lacson, Eduardo, Jr.;Landis, J. Richard
维持性血液透析的临床试验数据有限。将随机试验纳入透析临床护理交付应有助于产生实践指导性证据，但这种方法的可行性尚未建立。方法为了开发将试验嵌入维持性血液透析常规交付的方法，我们进行了一个群集随机，务实的试验示范项目，时间减少死亡率在终末期肾病（时间）试验，评估疗程持续时间对死亡率（主要结局）和住院率的影响。随机分配到干预组的透析机构对事件患者采用了>= 4.25小时（255分钟）的默认会话持续时间;随机分配到常规护理组的患者没有试验驱动的会话持续时间方法。实施是高度集中的，没有现场研究人员，完全依赖临床获得的数据。我们使用多种策略，从事设施人员和参与patients.Results试验纳入7035事件患者从266个透析单位。我们在中位随访1.1年时终止了试验，因为组间疗程差异不充分。对于主要分析人群（估计体内水分的受试者）
Background Data from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established.Methods To develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration >= 4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients.Results The trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water