MEDICAL VS. SURGICAL TREATMENT OF ISCHEMIC NEPHROPATHY

这项试验的总体目标是检查 缺血性肾病的外科治疗与内科治疗比较 肾病的定义是肾功能不全与严重的 肾动脉实质外闭塞症。反过来，肾脏 肾功能不全定义为肾小球滤过率(GFR)小于60 毫升/分钟。由于严重氮质血症患者的管理目标是 将重大相关疾病事件的发生频率降至最低，延长透析时间- 自由生存，澄清矫治严重的影响 肾血管闭塞症对这些目标的研究具有重大意义 这类患者的生存质量和医疗费用 与他们在整个国家的管理有关。具体来说， 目标是随机分配一组招募的患者 标准内科治疗或外科手术治疗的缺血性肾病 管理(肾血管重建术)与医疗管理相结合 以确定手术矫正此类疾病对患者的影响 GFR和生活质量指标的恶化速度。这场审判 检验了手术矫正肾动脉闭塞的假说 疾病会对肾功能状态产生有益的影响，其发生率 恶化，从而影响这些患者的生活质量。这个 感兴趣的原发肾功能结果是 肾血管重建术对一年内肾小球滤过率连续变化的影响 观察的能力。生存、非透析生存、成本和利用 卫生保健资源和生活质量的衡量标准将是 对研究期间(一至五年)进行比较评估。 为了进行这项研究，一组135名GFR患者(年龄18-75岁) &lt；60毫升/分钟，但满足纳入/排除标准的15毫升/分钟将是 随机分为手术加内科治疗或内科治疗 在四年的时间里单独使用(每年34名患者)。跟随 随机和手术(在一半的组中)，患者将 随后对GFR、生活质量指标进行了系列测量，以及 卫生保健资源的成本和利用的措施。

The overall objective of the trial is to examine the relative value of surgical versus medical treatment of ISCHEMIC NEPHROPATHY ISCHEMIC NEPHROPATHY is defined as renal insufficiency associated with severe extraparenchymal occlusive disease of the renal artery. In turn, renal insufficiency is defined as a glomerular filtration rate (GFR) less than 60 ml/min. Since the goals of management in severely azotemic patients are to minimize the frequency of major related morbid events and prolong dialysis- free survival, clarification of the impact of correction of severe renovascular occlusive disease on these goals has major significance for both the quality of survival for such patients and the health care costs associated with their management in the nation as a whole. Specifically, the objective is to allocate randomly a group of recruited patients with ISCHEMIC NEPHROPATHY to either standard medical treatment alone or surgical management (renal revascularization) combined with medical management in order to identify the impact of surgical correction of such disease on the rate of deterioration in GFR and on quality of life indicators. This trial tests the hypothesis that surgical correction of the renal artery occlusive disease will have a salutary effect on renal function status, its rate of deterioration, and, thereby, the quality of life in these patients. The primary renal function outcome of interest is the comparative effect of renal revascularization on sequential changes in GFR over a one year period of observation. Survival, dialysis-free survival, cost and utilization of health care resources, and measures of quality of life will be comparatively assessed for the duration of the study (one to five years). To perform this study, a group of 135 patients (age 18-75 years) with GFR <60 ml/min but >15 ml/min who satisfy inclusion/exclusion criteria will be randomized to either surgical plus medical treatment or medical management alone over a four-year period (34 patients each year). Following randomization and surgery (in one-half of the group), patients will be followed with serial measurements of GFR, quality of life indicators, and measures of cost and utilization of health care resources.