Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- cerebro-cardiovascular mortality
研究概览
简要总结
The purpose of this study is to evaluate the impact of the optimal and late initiation of dialysis on the mortality and quality of life in end-stage renal disease (ESRD) patients by the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation for the assessment of timing of dialysis initiation established by Fuzzy mathematics.
详细描述
The optimal time of dialysis initiation is still controversial. Estimated glomerular filtration rate (eGFR) which is now widely used as the assessment of timing of dialysis is lack of specificity. Some clinical factors such as heart failure, volume overload, malnutrition also determine the dialysis time. But these subjective judgements do not have a standard. So there is no quantitative assessment of timing of dialysis initiation. The research team developed a novel equation named DIFE (Dialysis Initiation based on Fuzzy mathematics Equation) with data from a retrospective multicenter cohort by fuzzy mathematical methods to combine these clinical factors and lab indexes. The DIFE was confirmed to be more accurate and convenient to use in clinical practice than eGFR only at the assessment of dialysis initiation time in the internal validation. For further validation of the DIFE, the team will conduct a multicenter randomized controlled trial. Patients who need hemodialysis will be randomized to optimal start dailysis group or late start dailysis group by the assessment of the DIFE. Based on the comparison of the two groups, this trial will provide evidence for the optimal timing of dialysis initiation in patients with end-stage renal disease by the DIFE.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35
- •Expected to commence maintenance hemodialysis as their renal replacement treatment
- •Agreeable to randomization
排除标准
- •Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD)
- •With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis
- •Have received or planning to receive a kidney transplant or peritoneal dialysis during the study
- •Has a recently diagnosed cancer that was likely to affect survival (except for the following cases: the cancer has been confirmed to be cured or relieved for over 5 years, have had the radical resection for the basal cell carcinoma or squamous carcinoma of skin or carcinoma in-situ of any part of the body )
- •Hepatocirrhosis
- •Positive test of Human Immunodeficiency Virus (HIV), the hepatitis B virus antigen (HBsAg) or anti-hepatitis C virus antibody (HCV Ab)
- •Acute infection within 1 month
- •Bad habit which is difficult to withdrawal such as alcohol abuse
- •Poor compliance and could not be treated according to the protocol
- •Being pregnant, nursing or having a plan for pregnancy
- •Life expectancy less than 1 year
- •The investigator confirm that should not enroll in the study with any other cases
研究组 & 干预措施
optimal start dialysis group
The DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE reaching to 30-35, which defined as the optimal start time.
干预措施: optimal start time (Other)
late start dialysis group
the DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE less than 30, which defined as late start time.
干预措施: late start time (Other)
结局指标
主要结局
cerebro-cardiovascular mortality
时间窗: 3 years, from the date of enrollment until the end of study
proportion of patients who die from cerebro-cardiovascular disease
all-cause mortality
时间窗: from the date of enrollment until the end of study, assessed up to 3 years
proportion of patients who die from any cause
次要结局
- Nutrition assessment(from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years)
- the change of quality of life(from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years)
- cognitive dysfunction(from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years)
- hospitalization(from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years)
- cerebro-cardiovascular events(from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years)
- Medical cost(from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years)
- Hemodialysis complications(from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years)
研究者
Lin Hongli
Director of Nephrology Department, The First Affiliated Hospital of Dalian Medical University
The First Affiliated Hospital of Dalian Medical University