Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 2,200
- 主要终点
- Primary and secondary patency rate of AVF
研究概览
简要总结
The timing for arteriovenous fistula (AVF) creation and its effect on target organs in patients with chronic renal failure will be investigated by multicenter prospective cohort. Lower estimated glomerular filtration rate (eGFR) patients (eGFR<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) and higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF creation. Maturation rate and time of AVF will be followed up in 3 months; primary and secondary patency rate of AVF, AVF construction on cardiac structure, function, encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF creation
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic renal failure, without AVF creation;
- •Estimated glomerular filtration rate (eGFR) <15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<20ml/min 1.73m2 for diabetic kidney disease;
- •All study subjects must agree to participate in the study and provide written informed consent.
排除标准
- •Patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement;
- •Contraindications to AVF construction:
- •Allen's Test is positive, or arterial diameter<2 mm; venous diameter<2.5 mm or venous occlusion/stenosis.
- •Local infection.
- •Have any other uncontrolled medical condition (severe heart failure, malignancy, severe coagulation disorders ).
- •Mental illness that makes the patients unable to complete the trial.
- •Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception.
结局指标
主要结局
Primary and secondary patency rate of AVF
时间窗: 2 years
Assessed by duplex ultrasound
Maturation rate of AVF
时间窗: 3 months
Assessed by duplex ultrasound. A mature fistula has a flow of over 500 mL/min,is less than 0.6 cm below the surface of the skin, and has a minimal diameter of 0.6 cm
次要结局
- AVF creation on ventricular volumes and left ventricular remodeling(2 years)
- AVF creation on AVF creation on brain MRI and cognitive functions(2 years)
- Maturation time of AVF(3 months)
- Complications of AVF(2 years)
研究者
Changlin Mei
Professor, Director, Division of Nephrology
Shanghai Changzheng Hospital