SPIDA: Surveillance and Proactive Intervention for Dialysis Access

Sponsor

University of Hull (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01391975

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the blood vessels. Methods of detecting narrowing are available and, more importantly, can detect narrowings before a fistula fails. It is not known whether treating these narrowings will actually improve fistula survival or if the majority can be left alone. we wish to see if we can detect such narrowings with ultrasound scanning and if early detection and treatment improves patient outcomes.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure Arteriovenous Fistula	Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Multi Centre Randomized Controlled Trial of the Clinical and Cost Effectiveness of Duplex Ultrasound Surveillance With Proactive Intervention Versus no Surveillance and Reactive Intervention for the Management of Stenosis in Arterio-venous Fistulae for Dialysis Vascular Access.

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surveillance and proactive intervention	Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis Regular duplex ultrasound assessment of fistula from time of creation until 6 months post procedure with referral of all haemodynamically significant stenoses to further imaging and treatment
No Intervention: Control and reactive intervention

Arm

Intervention/Treatment

Experimental: Surveillance and proactive intervention

Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis

Regular duplex ultrasound assessment of fistula from time of creation until 6 months post procedure with referral of all haemodynamically significant stenoses to further imaging and treatment

No Intervention: Control and reactive intervention

Outcome Measures

Primary Outcome Measures

Cumulative or secondary patency [within 6 months of fistula formation]
This being the interval from the time of access placement until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access.

Secondary Outcome Measures

Number of thrombosis events [within 6 months of fistula formation]
Number of fistula failures [within 6 months of fistula formation]
Number, type and technical success rate for elective interventions [within 6 months of fistula formation]
Number, type and technical success rate of acute interventions [within 6 months of fistula formation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
Ability to give informed written consent
Aged over 18 at time of referral