Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure

Study Overview
=================
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

Official Title
-----------------
Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure

Conditions
-----------------
Renal Failure, Chronic

Intervention / Treatment
-----------------
* Procedure: Lower eGFR for AVF construction
* Procedure: Higher eGFR for AVF construction


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower eGFR for AVF creation<br> | Procedure: Lower eGFR for AVF construction<br>* 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<br>* Other names: late AVF construction;|
| Active Comparator: Higher eGFR for AVF creation<br> | Procedure: Higher eGFR for AVF construction<br>* 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<br>* Other names: early AVF construction;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation rate of AVF | 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 | 3 months | 
| Primary and secondary patency rate of AVF | Assessed by duplex ultrasound | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation time of AVF | Assessed by duplex ultrasound | 3 months | 
| Complications of AVF | Assessed by duplex ultrasound | 2 years | 
| AVF creation on ventricular volumes and left ventricular remodeling | Assessed by doppler echocardiography | 2 years | 
| AVF creation on AVF creation on brain MRI and cognitive functions | Cognitive functions are assessed by psychic and autonomy scores | 2 years |