Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Fistula Maturity
Study Overview
Brief Summary
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is unknown.The study proposes a randomized clinical trial comparing the clinical and economic impact of early vs late angioplasty in non-maturing AVFs.
The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6 months, but a greater long-term AVF patency , lower requirement of subsequent interventions to maintain AVF patency for dialysis, and lower overall cost of access maintenance.
Detailed Description
The optimal timing of intervention in non-maturing AVFs remains controversial, and can only be definitively addressed by a randomized clinical trial (RCT) comparing early (6 weeks) vs late (3 months) angioplasty of non-maturing AVFs. The investigators will perform a single-center, prospective RCT. The investigators will recruit 112 patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients will be randomized to one of two groups: an early intervention group that will undergo a routine PTA at 6 weeks after AVF creation, or a late intervention group in which early PTA will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity. These patients will be followed for 2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with End stage renal disease (ESRD).
- •Patients on hemodialysis.
- •Patients using central venous catheter (CVC).
- •Patients who had a new AVF created after commencing dialysis.
- •Patients who had immature fistula ( 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min).
Exclusion Criteria
- •Children with Age below 18
Arms & Interventions
early angioplasty
Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who an early angioplasty intervention group that will undergo a routine Angioplasty at 6 weeks after AVF creation
Intervention: early Angioplasty (Procedure)
late Angioplasty
Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who a late angioplasty intervention group in which early Angioplasty will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity
Intervention: late Angioplasty (Procedure)
Outcomes
Primary Outcomes
Fistula Maturity
Time Frame: baseline- 6 months
Ultrasound of the fistula: Mature fistula Criteria: 1. Blood flow of at least 500 ml/min and 2. Minimum diameter of 4 mm
Secondary Outcomes
- Fistula survival(baseline-2 years)
- Fistula adequacy(Baseline- 2 years)
Investigators
Alian Al-Balas
Prinicipal investigator
University of Alabama at Birmingham