Departments of Medicine.
Community Health Sciences, and.
Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1831-1840. doi: 10.2215/CJN.01030117. Epub 2017 Oct 10.
Intradialytic hypotension (IDH) is associated with morbidity. The effect of blood volume-guided ultrafiltration biofeedback, which automatically adjusts fluid removal rate on the basis of blood volume parameters, on the reduction of IDH was tested in a randomized crossover trial.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We performed a 22-week, single blind, randomized crossover trial in patients receiving maintenance hemodialysis who had >30% of sessions complicated by symptomatic IDH in five centers in Calgary, Alberta, Canada. Participants underwent a 4-week run-in period to standardize dialysis prescription and dry weight on the basis of clinical examination. Those meeting inclusion criteria were randomized to best clinical practice hemodialysis (control) or best clinical practice plus blood volume-guided ultrafiltration biofeedback (intervention) for 8 weeks, followed by a 2-week washout and subsequent crossover for a second 8-week phase. The primary outcome was rate of symptomatic IDH.
Thirty-five participants entered, 32 were randomized, and 26 completed the study. The rate of symptomatic IDH with biofeedback was 0.10/h (95% confidence interval, 0.06 to 0.14) and 0.07/h (95% confidence interval, 0.05 to 0.10) during control (=0.29). There were no differences in the rate or proportion of sessions with asymptomatic IDH or symptoms alone. Results remained consistent when adjusted for randomization order and study week. There were no differences between intervention and control in the last study week in interdialytic weight gain (difference [SD], -0.02 [0.8] kg), brain natriuretic peptide (1460 [19,052] ng/L), cardiac troponins (3 [86] ng/L), extracellular water-to-intracellular water ratio (0.05 [0.33]), ultrafiltration rate (1.1 [7.0] ml/kg per hour), and dialysis recovery time (0.43 [19.25] hours).
The use of blood volume monitoring-guided ultrafiltration biofeedback in patients prone to IDH did not reduce the rate of symptomatic IDH events.
透析中低血压（IDH）与发病率有关。在一项随机交叉试验中，我们测试了基于血容量参数自动调整液体清除率的血容量引导超滤生物反馈对降低 IDH 的效果。
设计、地点、参与者和测量：我们在加拿大阿尔伯塔省卡尔加里的 5 个中心进行了一项为期 22 周、单盲、随机交叉试验，纳入了接受维持性血液透析且有 >30%的透析过程伴有症状性 IDH 的患者。参与者进行了 4 周的预试验期，以基于临床检查标准化透析处方和干体重。符合纳入标准的患者被随机分配至最佳临床实践血液透析（对照组）或最佳临床实践加血容量引导超滤生物反馈（干预组）8 周，随后进行 2 周洗脱期，随后进行第二次 8 周交叉期。主要结局是症状性 IDH 的发生率。
35 名患者入组，32 名患者被随机分组，26 名患者完成了研究。使用生物反馈时症状性 IDH 的发生率为 0.10/h（95%置信区间，0.06 至 0.14），而在对照组中为 0.07/h（95%置信区间，0.05 至 0.10）（=0.29）。无症状 IDH 或仅有症状的透析发生率或比例无差异。调整随机分组顺序和研究周后，结果仍保持一致。在最后一个研究周，干预组和对照组之间的透析间体重增加（差值[标准差]，-0.02[0.8]kg）、脑利钠肽（1460[19,052]ng/L）、心肌肌钙蛋白（3[86]ng/L）、细胞外水/细胞内水比值（0.05[0.33]）、超滤率（1.1[7.0]ml/kg·h）和透析恢复时间（0.43[19.25]h）均无差异。
在易发生 IDH 的患者中使用血容量监测引导的超滤生物反馈并不能降低症状性 IDH 事件的发生率。
