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

Not Applicable

• Conditions: Renal Failure, Chronic
• Interventions: Procedure: Lower eGFR for AVF construction; Procedure: Higher eGFR for AVF construction

• Registration Number: NCT02259296
• Lead Sponsor: Shanghai Changzheng Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-23
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-07
• Last Update Submitted: 2014-10-07
• Study First Posted: 2014-10-08
• Last Update Posted: 2014-10-08
• Study Start: 2015-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower eGFR for AVF creation	Lower eGFR for AVF construction	-
Higher eGFR for AVF creation	Higher eGFR for AVF construction	-

Primary Outcome Measures

Name	Time	Method
Primary and secondary patency rate of AVF	2 years	Assessed by duplex ultrasound
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

Secondary Outcome Measures

Name	Time	Method
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
Maturation time of AVF	3 months	Assessed by duplex ultrasound
Complications of AVF	2 years	Assessed by duplex ultrasound