Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas

Immature Arteriovenous Fistula Clinical Trial

Official title:

Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245944
• Other study ID #: F0001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Immature Arteriovenous Fistula

Intervention

Procedure:
• early Angioplasty
Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Early means pt will get the procedure at 6 weeks from time of initiation of AVFs
• late Angioplasty
Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Late means the angioplasty is done at 3 months from time of AVF creation if still immature at that time.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula Maturity	Ultrasound of the fistula: Mature fistula Criteria: Blood flow of at least 500 ml/min and; Minimum diameter of 4 mm	baseline- 6 months
Secondary	Fistula survival	Ultrasound of the fistula: Blood flow of at least 500 ml/min and; Minimum diameter of 4 mm	baseline-2 years
Secondary	Fistula adequacy	Fistula is used for hemodilaysis and provide adequate clearance which is measured by: Kt/V: 1.4 where K: clearance [m3/s], t: time [m3/s], V:volume of distribution [m3]	Baseline- 2 years