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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Renal Failure, Chronic

Treatments: Procedure: Higher eGFR for AVF construction; Procedure: Lower eGFR for AVF construction

Study type: Interventional

Funder types: Other

Identifiers

NCT02259296

CZHKI-HDVA-001

Details and patient eligibility

About

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

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,200 participants in 2 patient groups

Lower eGFR for AVF creation

Experimental group

Treatment:

Procedure: Lower eGFR for AVF construction

Higher eGFR for AVF creation

Active Comparator group

Treatment:

Procedure: Higher eGFR for AVF construction