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

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 Overview

• Status: Unknown
• Conditions: Renal Failure, Chronic
• Intervention / Treatment: Procedure: Lower eGFR for AVF construction; Procedure: Higher eGFR for AVF construction

• Study Type: Interventional
• Enrollment (Anticipated): 2200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Gao; Phone Number: +862181885397; Email: gaoxiang43100636@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower eGFR for AVF creation	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; Other Names: late AVF construction
Active Comparator: Higher eGFR for AVF creation	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; 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

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Collaborators: First Affiliated Hospital of Zhejiang University; The First Affiliated Hospital of Zhengzhou University; Zhongda Hospital; Sichuan Provincial People's Hospital; Beijing Haidian Hospital; The Second Affiliated Hospital of Dalian Medical University
• Investigators: Principal Investigator: Changlin Mei, Division of Nephrology, Changzheng Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): October 8, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Failure, Chronic; Fistula; Renal Insufficiency; Arteriovenous Fistula
• Other Study ID Numbers: CZHKI-HDVA-001