REDUCTION IN MORTALITY & MORBIDITY IN HEMODIALYSIS

死亡率降低

• 批准号: 3551012
• 负责人: GERALD SCHULMAN
• 金额: $ 11.96万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 1995-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3551012
• 关键词: chronic renal failure; cooperative study; hemodialysis; human subject; human therapy evaluation

The gross mortality of patients in the United States with end-stage renal disease (ESRD) treated by hemodialysis (HD) has increased over the past decade. This has occurred despite numerous advances in the technology associated with HD, and compares unfavorably with trends in other developed nations. The goal of this project is to conduct a Pilot Study which will determine the feasibility of implementing a larger multi-center, prospective, randomized trial to assess the effects of different hemodialysis techniques upon morbidity and mortality. At least 50 chronic HD patients stratified for comorbid illnesses from each of 3 centers will be randomized into a 2 (4) factorial study examining the effects of dialysis modality (high efficiency vs high flux), membrane type (cellulosic vs polysulfone) and dialysis prescription (KT/V 0.851.0 vs 1.2-1.4) delivered over 3 or 4 hours time. Because certain patient-related factors such as age, gender, nutritional status, blood pressure (BP) , presence of diabetes mellitus and condition of the HD access, can interact with the treatment-related variables to be tested in the study, a program of high quality medical care will be undertaken in a uniform manner for all subjects entered. The major outcome of this Pilot Study is the determination of the feasibility of conducting a larger study, by the assessment of the ability to achieve recruitment, retention and compliance of subjects; and the assessment of the frequency of the occurrence of clinical events such as the withdrawal for medical reasons or due to adverse effects of the experimental protocols.

美国终末期肾病患者的总死亡率 过去，通过血液透析（HD）治疗的疾病（ESRD）有所增加 十年。尽管技术取得了许多进步，但这种情况还是发生了 与 HD 相关，并且与其他领域的趋势相比不利 发达国家。 该项目的目标是进行试点研究 这将决定实施更大规模的可行性 多中心、前瞻性、随机试验来评估效果 不同的血液透析技术对发病率和死亡率的影响。 至少 50 名慢性 HD 患者根据 3 种疾病中的每一种的共存疾病进行分层 中心将被随机分为一项 2 (4) 析因研究，检查 透析方式（高效率与高通量）、膜的影响 类型（纤维素与聚砜）和透析处方（KT/V 0.851.0 vs 1.2-1.4）在 3 或 4 小时内交付。 因为某些 患者相关因素，如年龄、性别、营养状况、血液 血压 (BP)、糖尿病的存在和 HD 的状况 访问，可以与要测试的治疗相关变量进行交互 该研究将在 所有参加的科目均采用统一方式。 本次试点的主要成果 研究是确定进行更大规模的可行性 研究，通过评估实现招聘、保留的能力 和受试者的合规性；以及频率的评估 发生临床事件，例如因医疗原因退出 或由于实验方案的不利影响。