Clinical trial NCT02259296: Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
Official title: Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure, Chronic
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Zhongda Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Sichuan Provincial People's Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: Beijing Haidian Hospital
First posted: 2014-10-08
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Maturation rate of AVF
timeFrame: 3 months
measure: Primary and secondary patency rate of AVF
timeFrame: 2 years
Secondary outcomes:
measure: Maturation time of AVF
timeFrame: 3 months
measure: Complications of AVF
timeFrame: 2 years
measure: AVF creation on ventricular volumes and left ventricular remodeling
timeFrame: 2 years
measure: AVF creation on AVF creation on brain MRI and cognitive functions
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Division of Nephrology, Changzheng Hospital
name: Changlin Mei
role: PRINCIPAL_INVESTIGATOR
References: