Renal Failure, Chronic
Conditions
Brief summary
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
Interventions
PROCEDURELower eGFR for AVF construction
Lower eGFR patients (eGFR\<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<15ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction
PROCEDUREHigher eGFR for AVF construction
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) are proposed to undergo AVF construction
Sponsors
First Affiliated Hospital of Zhejiang University
Zhongda Hospital
The First Affiliated Hospital of Zhengzhou University
Sichuan Provincial People's Hospital
The Second Affiliated Hospital of Dalian Medical University
Beijing Haidian Hospital
Shanghai Changzheng Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maturation rate of AVF | 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 |
| Primary and secondary patency rate of AVF | 2 years | Assessed by duplex ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maturation time of AVF | 3 months | Assessed by duplex ultrasound |
| Complications of AVF | 2 years | Assessed by duplex ultrasound |
| AVF creation on ventricular volumes and left ventricular remodeling | 2 years | Assessed by doppler echocardiography |
| AVF creation on AVF creation on brain MRI and cognitive functions | 2 years | Cognitive functions are assessed by psychic and autonomy scores |
Contacts
Primary ContactXiang Gao
Outcome results
None listed