MORTALITY & MORBIDITY IN HEMODIALYSIS PATIENTS:
死亡
基本信息
- 批准号:6176545
- 负责人:
- 金额:$ 19.93万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:1994
- 资助国家:美国
- 起止时间:1994-09-30 至 2002-08-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
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.
美国国立卫生研究院主办的“血液透析患者的死亡率和死亡率:全
量表试验”是一项为期7年的前瞻性随机多中心研究,
为了确定增加的血液透析输送剂量和/或
使用高通量/生物相容性透析器膜,降低死亡率
和终末期肾病(ESRD)患者的发病率。九-
将由15个临床中心(60
患者/中心),采用2 x 2析因设计,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
2)高通量/生物相容性或低通量/生物不相容性
透析膜所有原因导致的死亡率将是主要的
终点。 次要结局指标将包括评估的发病率
特别强调非血管通路相关住院治疗
心血管并发症和严重感染,以及
血清白蛋白下降作为营养状况的指标。
埃默里临床中心建议从4亚特兰大招募参与者
透析单位,其中三个附属于埃默里大学(REN
亚特兰大,REN Emory Il,DCI Crawford Long)和一个社区透析
中心(REN皮埃蒙特)。合并后的人口普查包括328个中心
维持性血液透析患者,其中258例(79%)符合条件
根据MMHD方案中概述的标准(目标=108
患者/中心)。由于我们的转介基础和我们的种族混合,
社区,88%的患者是黑人,11%是高加索人,
其余1%为西班牙裔或东方裔; 46%为男性,54%为女性。
所有透析设备均配备高通量血液透析,95%
的患者耐受透析器血流量等于或大于400
对于参与的透析单位,平均KT/V为1.26
标准化蛋白质分解率(PCRN)为0.91
(范围:0.32-2.19)1994年2月(N= 328)。主要研究者,
合作研究者、研究协调员和营养师/数据收集员
既往合作临床试验、临床研究经验
在血液透析患者中,并有能力管理ESRD
患者 在以前的临床研究中,我们已经成功地在患者
招募,实现高水平的患者保留和依从性
以及质量控制措施。 因此,我们有信心
我们有足够的病人和专业知识
完成这项临床试验
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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JAMES L. BAILEY其他文献
JAMES L. BAILEY的其他文献
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