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

Renal Failure, Chronic Clinical Trial

— TACTIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02259296
• Other study ID #: CZHKI-HDVA-001
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2014
• Last updated: October 7, 2014
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2014
• Source: Shanghai Changzheng Hospital
• Contact: Xiang Gao
• Phone: +862181885397
• Email: gaoxiang43100636[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Kidney Failure, Chronic
• Renal Failure, Chronic
• Renal Insufficiency

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	Beijing Haidian Hospital, First Affiliated Hospital of Zhejiang University, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Dalian Medical University, Zhongda Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Primary and secondary patency rate of AVF	Assessed by duplex ultrasound	2 years	No
Secondary	Maturation time of AVF	Assessed by duplex ultrasound	3 months	No
Secondary	Complications of AVF	Assessed by duplex ultrasound	2 years	No
Secondary	AVF creation on ventricular volumes and left ventricular remodeling	Assessed by doppler echocardiography	2 years	No
Secondary	AVF creation on AVF creation on brain MRI and cognitive functions	Cognitive functions are assessed by psychic and autonomy scores	2 years	No