Medical Department, Renal Therapy Services-Latin America, Bogotá, DC, Colombia.
Epidemiology Department, Universidad Nacional de Colombia, Bogotá, DC, Colombia.
Ther Apher Dial. 2021 Feb;25(1):33-43. doi: 10.1111/1744-9987.13506. Epub 2020 May 29.
Expanded hemodialysis (HDx) provides increased clearance of conventional and large middle molecules through innovative medium cutoff (MCO) membranes. However, there is a paucity of real-world data regarding the benefits and safety of HDx. This large observational study evaluated outcomes among patients in Colombia undergoing HDx at a extended dialysis clinical services provider. This was a prospective single cohort study of prevalent patients who were treated with HDx; baseline information was collected from the most recent data before patients were started on HDx. Patients were followed prospectively for 1 year for changes in serum albumin and other laboratory parameters compared with the baseline. Survival, hospitalization and safety were assessed from the start of HDx. A total of 1000 patients were invited to enroll; 992 patients met the inclusion criteria for data analysis and 638 patients completed the year of follow-up. Seventy-four (8%) patients died during 866 patient-years (PY) of follow-up; the mortality rate was 8.54 deaths/100 PY (95% confidence interval [CI], 6.8-10.7). There were 673 hospitalization events with a rate of 0.79 events/PY (95% CI, 0.73-0.85) with 6.91 hospital days/PY (95% CI, 6.74-7.09). The observed variability from baseline and maximum average change in mean serum albumin levels were -1.8% and -3.5%, respectively. No adverse events were related to the MCO membrane. HDx using an MCO membrane maintains stable serum albumin levels and is safe in terms of nonoccurrence of dialyzer related adverse events.
扩大血液透析 (HDx) 通过创新的中等截留 (MCO) 膜提供了对常规和大分子物质的更高清除率。然而,关于 HDx 的益处和安全性的真实世界数据却很少。这项大型观察性研究评估了在一家扩展透析临床服务提供商接受 HDx 治疗的哥伦比亚患者的结局。这是一项对接受 HDx 治疗的现有患者进行的前瞻性单队列研究;基线信息是从患者开始接受 HDx 之前的最近数据中收集的。患者前瞻性随访 1 年,以比较基线时血清白蛋白和其他实验室参数的变化。从开始接受 HDx 起,评估了生存率、住院率和安全性。共邀请了 1000 名患者参加;992 名患者符合数据分析的纳入标准,638 名患者完成了 1 年的随访。在 866 患者年(PY)的随访期间,74 名(8%)患者死亡;死亡率为 8.54 例/100 PY(95%置信区间 [CI],6.8-10.7)。有 673 例住院事件,发生率为 0.79 例/PY(95% CI,0.73-0.85),住院天数为 6.91 天/PY(95% CI,6.74-7.09)。从基线观察到的变异和平均血清白蛋白水平的最大平均变化分别为 -1.8%和 -3.5%。没有与 MCO 膜相关的不良事件。使用 MCO 膜的 HDx 可维持稳定的血清白蛋白水平,且在不发生与透析器相关的不良事件方面是安全的。