Surveillance and Proactive Intervention for Dialysis Access

NCT01391975 | Withdrawn

• 1 other identifier: Access 6
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure; Arteriovenous Fistula

Keywords

arteriovenous fistula; surveillance; arterial stenosis; venous stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Surveillance and proactive intervention

EXPERIMENTAL

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

Control and reactive intervention

NO INTERVENTION

Interventions

Active ultrasound surveillance of fistula and proactive treatment of stenosis PROCEDURE

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

Surveillance and proactive intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to give informed written consent
• Aged under 18 at time of referral
• Inability to attend follow-up appointments
• Previous arteriovenous access procedures in target limb
• Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
• Known thrombophilic or thrombotic pathology

Sponsors & Collaborators

• University of Hull: lead

Study Sites (1)

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

GB (1)