Surveillance and Proactive Intervention for Dialysis Access

Not Applicable

Withdrawn

• Conditions: Renal Failure; Arteriovenous Fistula
• Interventions: Procedure: Active ultrasound surveillance of fistula and proactive treatment of stenosis

• Registration Number: NCT01391975
• Lead Sponsor: University of Hull

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

1. Inability to give informed written consent
2. Aged under 18 at time of referral
3. Inability to attend follow-up appointments

Specific exclusion;

1. Previous arteriovenous access procedures in target limb
2. Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
3. Known thrombophilic or thrombotic pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surveillance and proactive intervention	Active ultrasound surveillance of fistula and proactive treatment of stenosis	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 of thrombosis events	within 6 months of fistula formation
Number, type and technical success rate of acute interventions	within 6 months of fistula formation

Trial Locations

Locations (1)

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom