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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Interventions

  • Procedure: Lower 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
  • Procedure: Higher 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

Arms, Groups and Cohorts

  • Experimental: Lower eGFR for AVF creation
  • Active Comparator: Higher eGFR for AVF creation

Clinical Trial Outcome Measures

Primary Measures

  • Maturation rate of AVF
    • Time Frame: 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
    • Time Frame: 2 years
    • Assessed by duplex ultrasound

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Changzheng Hospital
  • Collaborator
    • First Affiliated Hospital of Zhejiang University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Changlin Mei, Professor, Director, Division of Nephrology – Shanghai Changzheng Hospital
  • Overall Official(s)
    • Changlin Mei, Principal Investigator, Division of Nephrology, Changzheng Hospital
  • Overall Contact(s)
    • Xiang Gao, +862181885397, gaoxiang43100636@163.com

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