Surveillance and Proactive Intervention for Dialysis Access

Renal Failure Clinical Trial

— SPIDA  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01391975
• Other study ID #: Access 6
• Status: Withdrawn
• Phase: N/A

Study information

• Verified date: March 2021
• Source: University of Hull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Renal Failure

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

Locations

Country	Name	City	State
United Kingdom	Hull Royal Infirmary	Hull

Sponsors (1)

Lead Sponsor	Collaborator
University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative or secondary patency	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.	within 6 months of fistula formation
Secondary	Number of thrombosis events		within 6 months of fistula formation
Secondary	Number of fistula failures		within 6 months of fistula formation
Secondary	Number, type and technical success rate for elective interventions		within 6 months of fistula formation
Secondary	Number, type and technical success rate of acute interventions		within 6 months of fistula formation