N Engl J Med. 2010 Dec 9;363(24):2287-300. doi: 10.1056/NEJMoa1001593. Epub 2010 Nov 20.
In this randomized clinical trial, we aimed to determine whether increasing the frequency of in-center hemodialysis would result in beneficial changes in left ventricular mass, self-reported physical health, and other intermediate outcomes among patients undergoing maintenance hemodialysis.
Patients were randomly assigned to undergo hemodialysis six times per week (frequent hemodialysis, 125 patients) or three times per week (conventional hemodialysis, 120 patients) for 12 months. The two coprimary composite outcomes were death or change (from baseline to 12 months) in left ventricular mass, as assessed by cardiac magnetic resonance imaging, and death or change in the physical-health composite score of the RAND 36-item health survey. Secondary outcomes included cognitive performance; self-reported depression; laboratory markers of nutrition, mineral metabolism, and anemia; blood pressure; and rates of hospitalization and of interventions related to vascular access.
Patients in the frequent-hemodialysis group averaged 5.2 sessions per week; the weekly standard Kt/V(urea) (the product of the urea clearance and the duration of the dialysis session normalized to the volume of distribution of urea) was significantly higher in the frequent-hemodialysis group than in the conventional-hemodialysis group (3.54±0.56 vs. 2.49±0.27). Frequent hemodialysis was associated with significant benefits with respect to both coprimary composite outcomes (hazard ratio for death or increase in left ventricular mass, 0.61; 95% confidence interval [CI], 0.46 to 0.82; hazard ratio for death or a decrease in the physical-health composite score, 0.70; 95% CI, 0.53 to 0.92). Patients randomly assigned to frequent hemodialysis were more likely to undergo interventions related to vascular access than were patients assigned to conventional hemodialysis (hazard ratio, 1.71; 95% CI, 1.08 to 2.73). Frequent hemodialysis was associated with improved control of hypertension and hyperphosphatemia. There were no significant effects of frequent hemodialysis on cognitive performance, self-reported depression, serum albumin concentration, or use of erythropoiesis-stimulating agents.
Frequent hemodialysis, as compared with conventional hemodialysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score but prompted more frequent interventions related to vascular access. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT00264758.).
在这项随机临床试验中,我们旨在确定增加中心血液透析的频率是否会导致接受维持性血液透析的患者的左心室质量、自我报告的身体健康和其他中间结果发生有益变化。
将患者随机分为每周进行 6 次血液透析(频繁血液透析,125 例)或每周 3 次血液透析(常规血液透析,120 例),持续 12 个月。两个主要复合结局是通过心脏磁共振成像评估的左心室质量的死亡或变化(从基线到 12 个月),以及 RAND 36 项健康调查的身体健康综合评分的死亡或变化。次要结局包括认知表现;自我报告的抑郁;营养、矿物质代谢和贫血的实验室标志物;血压;以及住院率和血管通路相关干预措施的发生率。
频繁血液透析组患者每周平均进行 5.2 次透析;频繁血液透析组每周标准 Kt/V(尿素)(尿素清除率与透析时间的乘积,按尿素分布容积标准化)明显高于常规血液透析组(3.54±0.56 vs. 2.49±0.27)。频繁血液透析与两个主要复合结局均显著相关(左心室质量死亡或增加的风险比为 0.61;95%置信区间 [CI],0.46 至 0.82;死亡或身体健康综合评分降低的风险比为 0.70;95%CI,0.53 至 0.92)。与常规血液透析相比,随机分配到频繁血液透析的患者更有可能接受血管通路相关的干预措施(风险比,1.71;95%CI,1.08 至 2.73)。频繁血液透析与高血压和高磷血症的控制改善有关。频繁血液透析对认知表现、自我报告的抑郁、血清白蛋白浓度或促红细胞生成素刺激剂的使用没有显著影响。
与常规血液透析相比,频繁血液透析与死亡或左心室质量变化以及死亡或身体健康综合评分变化的复合结局相关,但更频繁地需要进行血管通路相关干预。(由美国国立糖尿病、消化和肾脏疾病研究所等资助;ClinicalTrials.gov 编号,NCT00264758。)