Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Primary (composite): death, and hospitalisation
研究概览
简要总结
This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney disease (CKD) in order to determine the impact of specialised care by nephrologists compared to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation RRT) and c) patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CKD stage 3, 4 and 5 (CCl < 40 ml/min according to abbreviated MDRD formula) aged 18-80 years old and enrolled during a hospitalization.
排除标准
- •Patients previously known by nephrologists.
- •Estimated life expectancy < 1 year
- •Refusal or inability to sign writing consent
研究组 & 干预措施
nephrologists
Combined management PCP: nephrologists (at least 4 nephrology visits/year)
干预措施: specialised renal care (Behavioral)
Primary Care Physicians
Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG
干预措施: specialised renal care (Behavioral)
结局指标
主要结局
Primary (composite): death, and hospitalisation
时间窗: 24 months after enrollment
death and emergency hospitalisation during the following 2 years afterr andomisation
次要结局
- Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life(24 months after enrollment)
研究者
Patrick Saudan
Professor, MD
University Hospital, Geneva