HEMODIALYSIS VASCULAR ACCESS CLINICAL TRIALS CONSORTIUM

血液透析血管通路临床试验联盟

• 批准号: 6728229
• 负责人: MICHAEL ALLON
• 金额: $ 29.44万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-04-15 至 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6728229
• 关键词: blood disorder chemotherapy; blood tests; blood vessel disorder; clinical research; clinical trials; cooperative study; disease /disorder prevention /control; drug administration rate /duration; folate; hemodialysis; homocysteine; human subject; human therapy evaluation; longitudinal human study; medical complication; nutrition related tag; outcomes research; patient oriented research; statistics /biometry; vitamin therapy

DESCRIPTION (adapted from the application) The current approach to vascular access in dialysis patients consists of monitoring grafts and fistulas for evidence of stenosis, and intervening to correct the stenosis after it occurs. A pharmacologic intervention that prevents vascular access complications may markedly decrease the need for salvage procedures, access-related hospitalizations, and the overall cost of caring for hemodialysis patients. Plasma homocysteine levels are frequently elevated in dialysis patients. Hyperhomocysteinemia is a risk factor for cardiovascular disease in hemodialysis patients, and may also be a risk factor for vascular access thrombosis. Folate is a substrate for homocysteine, and folic acid administration can lower homocysteine levels. Whereas standard doses of folic acid (1 mg daily) have a minimal effect on homocysteine levels in dialysis patients, pharmacologic doses (15 mg daily) can reduce homocysteine levels substantially. It is not known whether aggressive reduction of homocysteine levels in dialysis patients with pharmacologic doses of folic acid can decrease the frequency of vascular access stenosis and thrombosis. The following hypotheses will be tested in this study: (1) Pharmacologic doses of folic acid (15 mg daily) are more effective than standard doses (1 mg daily) in decreasing the frequency of graft stenosis and thrombosis in hemodialysis patients. (2) This beneficial effect of high-dose folic acid on graft outcome is proportionate to the magnitude of reduction in plasma homocysteine. (3) High dose folic acid administration is effective in improving graft outcomes both as primary prophylaxis (no previous stenosis or thrombosis) and as secondary prophylaxis (prevention of recurrent stenosis or thrombosis after an initial event). The study design is a prospective, randomized, double-blind, multicenter investigation in which chronic hemodialysis patients with AV grafts will be randomized to receive either high (15 mg daily) or standard (1 mg daily) doses of folic acid supplements. The primary endpoint will be overall graft survival. Secondary endpoints will be the frequency of graft interventions and cardiovascular events. The results will be analyzed to determine whether there are significant differences in graft survival or complications between the groups receiving high dose and standard dose of folic acid.

描述（根据应用程序改编） 透析患者目前的血管通道方法包括 监测移植物和瘘管以证明狭窄的证据，并介入 发生狭窄后，纠正狭窄。一种药理学干预措施 防止血管通道并发症可能显着减少 打捞程序，与访问相关的住院以及整体成本 照顾血液透析患者。血浆同型半胱氨酸水平经常 透析患者升高。高脑结晶质血症是 血液透析患者的心血管疾病，也可能是危险因素 用于血管入口血栓形成。叶酸是同型半胱氨酸的底物，并且 叶酸给药可以降低同型半胱氨酸水平。而标准剂量 叶酸的（每天1毫克）对同型半胱氨酸水平的影响很小 透析患者，药理学剂量（每天15毫克）可以减少同型半胱氨酸 水平基本上。尚不知道是否积极地减少 透析患者的同型半胱氨酸水平的药理剂量的叶酸 可以降低血管访问狭窄和血栓形成的频率。 在本研究中将测试以下假设：（1）药物剂量 叶酸（每天15毫克）的有效性比标准剂量（每天1毫克）更有效 减少血液透析中移植狭窄和血栓形成的频率 患者。 （2）高剂量叶酸对移植结果的这种有益影响 与血浆同型半胱氨酸的减小幅度成正比。 （3）高 剂量叶酸给药可有效改善移植结局，因为 原发性预防（没有以前的狭窄或血栓形成）和次要 预防（预防初始狭窄或血栓形成后的复发性狭窄或血栓形成 事件）。 研究设计是一个前瞻性，随机，双盲，多中心 调查患有AV移植物的慢性血液透析患者将是 随机接收高（每天15毫克）或标准（每天1毫克）剂量 叶酸补充剂。主要终点将是总体移植生存。 次要终点将是移植干预措施的频率和 心血管事件。结果将进行分析以确定是否存在 在移植生存或并发症之间存在显着差异 接受高剂量和标准剂量的叶酸的组。