MORTALITY & MORBIDITY IN HEMODIALYSIS PATIENTS:

美国国立卫生研究院赞助的《血液透析患者的死亡率和发病率：全 量表试验“是一项为期7年的前瞻性、随机、多中心研究 以确定是否增加血液透析和/或 使用高通量/生物兼容的透析膜，降低死亡率 终末期肾病(ESRD)患者的发病率。九点- 15个临床中心(60个)将招募100名参与者 患者/中心)使用2 x 2析因设计，其中患者将 随机接受：1)KT/V为0.95(范围：0.9-1.1)或1.4(范围：1 .3-1.5)；以及2)高通量/生物相容或低通量/生物不亲和 透析膜。所有原因造成的死亡将是主要的 终结点。次要结果衡量标准将包括评估的发病率 来自非血管通路相关的住院治疗，特别强调 关于心血管并发症和严重感染，以及 作为营养状况指标的血清白蛋白下降。 埃默里临床中心建议从4个亚特兰大招募参与者 透析单元，其中三个附属于埃默里大学(REN 亚特兰大，Ren Emory Il，DCI Crawford Long)和一次社区透析 中心(任·皮埃蒙特)。合并后的人口普查包括328个中心 符合条件的维持性血液透析患者258例(79%) 根据MMHD协议中概述的标准(目标=108 患者/中心)。由于我们的推荐基础和我们的种族混杂 社区，我们88%的患者是黑人，11%是白人，而 剩下的1%是西班牙裔或东方人；46%是男性，54%是女性。 所有透析器都配备了高通量血液透析，95% 耐受透析器血流量等于或大于400的患者 毫升/分钟。对于参与的透析单元，平均KT/V为1.26 (范围：0.73~2.07)，归一化蛋白质分解率(PCRN)为0.91 (范围：0.32-2.19)1994年2月(N=328)。首席调查员， 联合调查员、研究协调员和营养师/数据收集者 以前在协作临床试验、临床研究方面的经验 在血液透析患者中，并胜任ESRD的管理 病人。在以前的临床研究中，我们在患者身上取得了成功 招聘，实现高水平的患者留住和遵从性 通过走访，以及质量控制措施。因此，我们有信心 我们有必要的病人数量和专业知识来成功 完成这项临床试验。

The NIH sponsored "Mortality and Morbidity in Hemodialysis Patients: Full- Scale Trial" is a 7 year prospective randomized multicenter study designed to determine whether an increased delivered dose of hemodialysis and/or the use of high-flux/biocompatible dialyzer membranes, reduces mortality and morbidity in patients with end-stage renal disease (ESRD). Nine- hundred participants will be recruited by 15 clinical centers (60 patients/center) utilizing a 2 x 2 factorial design where patients will be randomized to receive: 1) a KT/V of 0.95 (range: 0.9-1.1) or 1.4 (range:1 .3-1.5); and 2) high-flux/biocompatible or low flux/bioincompatible dialysis membranes. Mortality due to all causes will be the primary endpoint. Secondary outcomes measures will include morbidity as assessed from non-vascular access related hospitalizations with particular emphasis on cardiovascular complications and severe infections, as well as the decline in serum album in as an index of nutritional status. The Emory Clinical Center proposes to recruit participants from 4 Atlanta dialysis units, three of which are affiliated with Emory University (REN Atlanta, REN Emory Il, DCI Crawford Long), and one community dialysis center (REN Piedmont). The combined census includes 328 in-center maintenance hemodialysis patients of which 258 (79%) are eligible according to the criteria outlined in the MMHD protocol (goal=108 patients/center). Due to our referral base and the ethnic mix of our community, 88% of our patients are black, 11% are caucasian, and the remaining 1% are hispanic or oriental; 46% are male and 54% are female. All dialysis units are equipped to provide high-flux hemodialysis, and 95% of the patients tolerate a dialyzer blood flow equal to or more than 400 ml/min. For the participating dialysis units, the mean KT/V was 1.26 (range: 0.73-2.07) and normalized protein catabolic rate (PCRN) was 0.91 (range: 0.32-2.19) for February 1994 (N= 328). The Principal Investigator, Co-investigator's, Study Coordinator, and Dietician/Data Collector, have previous experience with collaborative clinical trials, clinical studies in hemodialysis patients, and are competent in the management of ESRD patients. In previous clinical studies we have been successful in patient recruitment, achieving high levels of patient retention and compliance with visits, as well as quality control measures. Thus, we are confident that we have the required number of patients and expertise to successfully complete this clinical trial.