Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China :a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The patency rate of vascular access
研究概览
简要总结
The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The elderly and very elderly with end stage renal disease.
- •Estimated glomerular filtration rate (eGFR) <20ml/min*1.73m2
- •All study subjects agree to participate in the study and provide written informed consent.
排除标准
- •Patients' life expectancy is less than 2 years.
- •Mental illness that makes the patients unable to complete the trial.
结局指标
主要结局
The patency rate of vascular access
时间窗: 2 years
Including primary and secondary patency rate.Blood flow can be above 500 mL/min in a mature arteriovenous fistula by ultrasound scan and 4 times of body weight (Kg\*4 mL/min) in a arteriovenous graft or tunneled cuffed catheter in dialysis practice.
Effect of vascular access construction on ventricular volumes and left ventricular remodeling
时间窗: 2 years
Assessed by doppler echocardiography
Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function
时间窗: 2 years
Cognitive functions are assessed by psychic and autonomy scores
次要结局
- Mortality due to vascular access(2 years)
- Cost-effectiveness of different vascular access(2 years)
- Complications of vascular access(2 years)
- Hospitalization rate due to vascular access.(2 years)
研究者
Changlin Mei
Professor, Director, Division of Nephrology
Shanghai Changzheng Hospital