Stanford University School of Medicine, Stanford, California, USA.
Palo Alto Medical Foundation, Palo Alto, California, USA.
Hemodial Int. 2020 Oct;24(4):480-486. doi: 10.1111/hdi.12869. Epub 2020 Aug 26.
We recently completed an Investigational Device Exemption (IDE) study in which 30 patients were enrolled (13 patients previously on home hemodialysis (HHD) and 17 patients new to HHD) and treated with the Tablo Hemodialysis System (Outset Medical, Inc., San Jose, CA) for 8 weeks in-center and 8 weeks in-home with an interim 2-4 week transition period for home training.
In addition to assessments of urea kinetics, events related to safety, and operational issues (e.g., alarm resolution), we obtained data on several parameters of health-related quality of life, including time to recovery (TTR), the EQ-5D-5L (a well-validated measure of general health status), and the quality of sleep and related symptoms, to further assess the safety of HHD with Tablo. We compared results obtained during the in-center and in-home phases of the trial.
Twenty-eight of 30 patients (93%) completed all trial periods. Adherence to the prescribed four treatments per week schedule was 96% in-center and 99% in-home. Median TTR was 1.5 hours (10th, 90th percentile range 0.17 to 12, mean TTR 3.68 ± 5.88 hours) during the in-center and 2 hours (10th, 90th percentile range 0 to 6.0, mean TTR 3.04 ± 5.14 hours) during the at-home phase (Wilcoxon signed rank p = 0.57). Median index values on the EQ-5D-5L were similar during the in-center (0.832, 10th, 90th percentile range 0.617 to 1, mean 0.817 ± 0.165) and in-home (0.826, 10th, 90th percentile range 0.603 to 1, mean 0.821 ± 0.163) trial phases (Wilcoxon signed rank p = 0.36). Patients reported feeling alert or well-rested with little difficulty falling or staying asleep or feeling tired and worn out when using Tablo in either environment.
When using Tablo in-home, patients reported similar TTR, general health status, and sleep quality and related symptoms compared to using Tablo in-center. (294 words).
我们最近完成了一项研究性设备豁免（IDE）研究，该研究纳入了 30 名患者（13 名之前接受家庭血液透析（HHD）治疗的患者和 17 名新接受 HHD 治疗的患者），并使用 Tablo 血液透析系统（Outset Medical，Inc.，加利福尼亚州圣何塞）进行了 8 周的中心治疗和 8 周的家庭治疗，期间有 2-4 周的过渡时间用于家庭培训。
除了评估尿素动力学、与安全性相关的事件和操作问题（例如，警报解决）外，我们还获得了与健康相关的生活质量的几个参数的数据，包括恢复时间（TTR）、EQ-5D-5L（一种经过充分验证的一般健康状况衡量标准）和睡眠质量及相关症状，以进一步评估 Tablo 进行 HHD 的安全性。我们比较了试验中心和家庭阶段的结果。
30 名患者中的 28 名（93%）完成了所有试验期。中心治疗期间每周规定的 4 次治疗的依从率为 96%，家庭治疗期间为 99%。中心治疗期间的中位 TTR 为 1.5 小时（第 10 百分位，第 90 百分位范围 0.17 至 12，平均 TTR 3.68±5.88 小时），家庭治疗期间为 2 小时（第 10 百分位，第 90 百分位范围 0 至 6.0，平均 TTR 3.04±5.14 小时）（Wilcoxon 符号秩检验，p=0.57）。中心治疗期间的 EQ-5D-5L 指数中位数为 0.832（第 10 百分位，第 90 百分位范围 0.617 至 1，平均 0.817±0.165），家庭治疗期间为 0.826（第 10 百分位，第 90 百分位范围 0.603 至 1，平均 0.821±0.163）（Wilcoxon 符号秩检验，p=0.36）。患者报告说，Tablo 无论在家庭环境还是中心环境下，使用后都感觉警觉或休息良好，入睡或保持睡眠或感到疲倦和疲惫的困难较小。
当患者在家中使用 Tablo 时，与在中心使用 Tablo 相比，他们报告的 TTR、总体健康状况和睡眠质量及相关症状相似。（294 字）
