Clinical trial NCT03245944: Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas
Official title: Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immature Arteriovenous Fistula
Keywords: immature AVF
percutaneous intervention
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fistula Maturity
timeFrame: baseline- 6 months
Secondary outcomes:
measure: Fistula survival
timeFrame: baseline-2 years
measure: Fistula adequacy
timeFrame: Baseline- 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References:
citation: Al-Balas A, Lee T, Young CJ, Barker-Finkel J, Allon M. Predictors of Initiation for Predialysis Arteriovenous Fistula. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1802-1808. doi: 10.2215/CJN.00700116. Epub 2016 Sep 14.
citation: Al-Balas A, Lee T, Young CJ, Kepes JA, Barker-Finkel J, Allon M. The Clinical and Economic Effect of Vascular Access Selection in Patients Initiating Hemodialysis with a Catheter. J Am Soc Nephrol. 2017 Dec;28(12):3679-3687. doi: 10.1681/ASN.2016060707. Epub 2017 Jul 14.