Tugman Matthew J, Narendra Julia H, Li Quefeng, Wang Yueting, Hinderliter Alan L, Brunelli Steven M, Flythe Jennifer E
University of North Carolina (UNC) Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, UNC School of Medicine, Chapel Hill, NC, USA.
Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
Contemp Clin Trials Commun. 2019 Jul 19;15:100415. doi: 10.1016/j.conctc.2019.100415. eCollection 2019 Sep.
Rapid fluid removal (ultrafiltration, UF) is associated with higher cardiovascular morbidity and mortality among individuals receiving maintenance hemodialysis (HD). Fluid removal rates that exceed vascular refill rates can result in hemodynamic instability, end-organ damage to the heart, kidneys, gut and brain, among other organs, and patient symptoms. There are no known evidence-based HD treatment strategies to reduce harm from higher UF rates. Ultrafiltration profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and plasma oncotic pressure, has been proposed as an HD treatment intervention that may reduce UF rate-related complications. This study is a randomized 4-phase cross-over trial in which participants are successively alternated between study arms with intervening washout periods, and treatment order is randomized. After 4-week screening and 6-week baseline periods, participants are randomized to HD with conventional UF or HD with UF profiling for a period of 3 weeks followed by a 1-week washout period before crossing over. Participants cross into conventional UF and UF profiling phases twice (2 phases per arm). The primary outcomes of interest are intradialytic hypotension (nadir intradialytic systolic blood pressure <90 mmHg), pre-to post-HD change in troponin T (expressed as a percentage), change in left ventricular global longitudinal strain (an echocardiographic measure of left ventricular systolic function), and development of intradialytic left ventricular stunning (worsening of contractile function in ≥2 segments). This study will determine the impact of UF profiling on UF rate-related cardiovascular complications in prevalent, maintenance HD patients.
在接受维持性血液透析（HD）的患者中，快速清除液体（超滤，UF）与较高的心血管发病率和死亡率相关。液体清除率超过血管再充盈率会导致血流动力学不稳定、心脏、肾脏、肠道和大脑等器官的终末器官损伤以及患者出现症状。目前尚无基于证据的HD治疗策略来减少较高超滤率带来的危害。超滤模式，即改变超滤率以在最大水合作用和血浆胶体渗透压期间最大化液体清除的做法，已被提议作为一种HD治疗干预措施，可能会减少与超滤率相关的并发症。本研究是一项随机4阶段交叉试验，参与者在各研究组之间依次交替，中间有洗脱期，且治疗顺序是随机的。在进行4周的筛查期和6周的基线期后，参与者被随机分配到采用传统超滤的HD组或采用超滤模式的HD组，为期3周，随后有1周的洗脱期，之后进行交叉。参与者进入传统超滤和超滤模式阶段各两次（每组2个阶段）。感兴趣的主要结局指标包括透析期间低血压（透析期间收缩压最低点<90 mmHg）、HD前后肌钙蛋白T的变化（以百分比表示）、左心室整体纵向应变的变化（一种评估左心室收缩功能的超声心动图指标）以及透析期间左心室顿抑的发生（≥2个节段的收缩功能恶化）。本研究将确定超滤模式对维持性HD患者中与超滤率相关的心血管并发症的影响。
