Division of Nephrology, Stanford University School of Medicine, Palo Alto, California.
Kidney360. 2021 Sep 16;2(11):1752-1760. doi: 10.34067/KID.0001922021. eCollection 2021 Nov 25.
We conducted this study to examine the effect of taking versus holding BP medications before hemodialysis on intradialytic hypotension (IDH).
In this cluster randomized trial, each dialysis unit was randomly designated as TAKE or HOLD units. Participants within a TAKE unit were instructed to take all BP medications as prescribed, whereas participants within a HOLD unit were instructed to hold medications dosed more than once daily before hemodialysis. The intervention lasted for 4 weeks. We hypothesized that TAKE would be noninferior to HOLD on the primary outcome of asymptomatic IDH, defined as ≥30% of sessions with nadir systolic BP <90 mm Hg and on the following secondary outcomes: uncontrolled hypertension (predialysis systolic BP >160 mm Hg), failure to achieve dry weight, and shortened dialysis sessions.
We randomized 10 dialysis units in a 1:1 ratio to TAKE or HOLD, which included 65 participants in TAKE and 66 participants in HOLD. We did not show that TAKE was noninferior to HOLD for the primary IDH outcome (mean unadjusted difference of 8%; 95% CI, -3% to 19%). TAKE was superior to HOLD for the outcome of uncontrolled hypertension (mean unadjusted difference of -15%, 95% CI, -28% to -1%). TAKE was noninferior to HOLD for the outcomes of failure to achieve dry weight and shortened dialysis sessions.
In this cluster randomized trial that randomized patients to either taking or holding BP medications before hemodialysis, a strategy of taking BP medications dosed more than once daily was not noninferior to holding BP medications for the primary outcome of IDH, but did reduce the occurrence of uncontrolled hypertension. Whether any potential benefit of holding BP medications on reducing IDH is offset by any potential harm related to higher predialysis BP remains to be seen.
我们开展这项研究旨在探讨血液透析前服用与维持血压药物对透析中低血压（IDH）的影响。
在这项聚类随机试验中，每个透析单元被随机指定为 TAKE 或 HOLD 单元。TAKE 单元中的参与者被指示按规定服用所有降压药物，而 HOLD 单元中的参与者被指示在血液透析前停止每日多次服用的药物。干预持续 4 周。我们假设 TAKE 在无症状 IDH 的主要结局（定义为 30%以上的治疗中出现收缩压最低点<90mmHg）和以下次要结局上不劣于 HOLD：未控制的高血压（透析前收缩压>160mmHg）、未达到干体重和透析时间缩短。
我们按 1:1 的比例将 10 个透析单元随机分为 TAKE 或 HOLD 组，每组包括 65 名 TAKE 组参与者和 66 名 HOLD 组参与者。我们没有证明 TAKE 在主要 IDH 结局上不劣于 HOLD（平均未调整差异为 8%，95%CI，-3%至 19%）。TAKE 在未控制的高血压结局上优于 HOLD（平均未调整差异为-15%，95%CI，-28%至-1%）。TAKE 在未达到干体重和透析时间缩短的结局上不劣于 HOLD。
在这项对血液透析前服用或维持血压药物的患者进行随机分组的聚类随机试验中，每日多次服用降压药物的策略在 IDH 的主要结局上不劣于维持降压药物，但确实减少了未控制的高血压的发生。关于维持血压药物是否可以降低 IDH，任何潜在的好处是否会被与更高的透析前血压相关的任何潜在危害所抵消，还有待观察。
