A Randomized, Controlled Trial to Evaluate Routine and Deferred Dialysis Initiation in Chinese Population
试验速览
- 阶段
- 不适用
- 入组人数
- 1,049
- 试验地点
- 1
- 主要终点
- All-cause mortality: Proportion of patients who die from any cause
研究概览
简要总结
This study evaluates the efficacy and safety of deferred dialysis initiation in Chinese population. 16 tertiary hospitals across China will be randomly assigned into routine and deferred dialysis groups.
详细描述
The timing for initiating dialysis for progressive chronic kidney disease (CKD) patients is an important issue yet is not well established. There is a strong trend to early dialysis initiation for end stage renal disease (ESRD) patients over the past decades. However, observational data found that early initiation seemed to produce no benefit but additional burden to patients and the health care system. The IDEAL study, the only randomized, controlled trial (RCT) on this issue, found that all-cause mortality, comorbidities and quality of life had no difference between early (glomerular filtration rate, GFR 10-14ml/min/1.73m2) and late (GFR 5-7ml/min/1.73m2) dialysis starters. However there was a big limitation in this study that the difference for average GFR between two groups (12 ml/min/1.73 m2 vs. 9.8 ml/min/1.73m2) was not so separate. Recently, the Canadian Society of Nephrology have released a clinical practice guideline on this issue. The guideline recommends an "intent-to-defer" approach for dialysis initiation and to initiate dialysis in the absence of symptoms in patients with an estimated GFR of 6 ml/min /1.73 m2 or less. In this guideline the specialists also express that the optimal management of patients with an estimated GFR of 6 ml/min per 1.73 m2 or less is based on limited data. There is a gap in knowledge. This research will further evaluate the efficacy and safety of deferred dialysis initiation and fill in this gap. In this study, algorithms will be adopted to determine the timing of dialysis initiation for both routine and deferred dialiysis groups, and the only difference in these two algorithms is the GFR level to initiate dialysis (7 Vs. <5 ml/min per 1.73 m2). The theory that blood access (arteriovenous fistulas) can be timely prepared according to the past GFR decline trajectory will also be tested.
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
- Single (Outcomes Assessor)
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
- •Nondialysis-dependent stable CKD stage 4-5 patients (eGFR>7ml/min /1.73 m2)
- •Willing to choose dialysis as his renal replacement therapy method
- •Heart function: grade I or II (NYHA Functional Classification)
排除标准
- •The life expectancy of patients is estimated to be short (due to causes other than kidney disease);
- •Acute infection occurred in one month;
- •Myocardial infarction, NYHA class IV or stroke events within 3 months;
- •Uncontrolled malignancy;
- •Active viral hepatitis;
- •Active rheumatic disease;
- •Pregnant women, women intending to conceive after enrollment or breastfeeding woman;
- •Planning to take kidney transplantation within the study period;
- •With indices of emergency dialysis;
- •eGFR less than 7 ml/min/1.73m2 in first visit;
- •Under other clinical studies which has an impact on this study;
- •Unable to provide written informed consent.
研究组 & 干预措施
Deffered Dialysis Initiation
Algorithm for deferred dialysis intervention:
initiating dialysis in the absence of symptoms in patients with an eGFR of 5 ml/min /1.73 m2 or less
干预措施: Algorithm for deferred dialysis intervention (Other)
Routine dialysis Initiation
Algorithm for routine dialysis intervention:
initiating dialysis in the absence of symptoms in patients with an eGFR of 7 ml/min /1.73 m2 (which is the average GFR for patients in Beijing to start dialysis )
干预措施: Algorithm for routine dialysis intervention (Other)
结局指标
主要结局
All-cause mortality: Proportion of patients who die from any cause
时间窗: From date of enrollment until the end of study, assessed up to 3 years
Proportion of patients who die from any cause during observation period.
Acute nonfatal cerebro-cardiovascular events after dialysis initiation
时间窗: From date of dialysis initiation until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year
Proportion of patients who suffer from acute nonfatal cerebro-cardiovascular events after dialysis initiation. Cerebro-cardiovascular events include acute myocardial infarction,acute coronary ischemia syndrome,acute heart failure, acute exacerbation of chronic heart failure ,severe arrhythmia, stroke, etc.
Acute nonfatal cerebro-cardiovascular events before dialysis initiation
时间窗: From date of enrollment until the date of dialysis initiation, or the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year
Proportion of patients who suffer from acute nonfatal cerebro-cardiovascular events before dialysis initiation. Cerebro-cardiovascular events include acute myocardial infarction,acute coronary ischemia syndrome,acute heart failure, acute exacerbation of chronic heart failure ,severe arrhythmia, stroke, etc.
次要结局
- Nutrition assessment(From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, performed every 3 months)
- Patient reported outcome of quality of life(From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, once every 3 months)
- Arteriovenous fistulas usage(From date of enrollment until the date of dialysis initiation, assessed up to 3 years)
- Hospitalization: Proportion of patients who are admitted to hospital(From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year)
- Complications of dialysis(From date of dialysis initiation until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year)
- Costs(From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, performed every 3 months)
- Catheter usage(From date of enrollment until the date of dialysis initiation, assessed up to 3 years)
研究者
Li Zuo
Head of the Nephrology Department
Peking University People's Hospital