Clinical Trial: Surveillance and Proactive Intervention for Dialysis Access

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: University of Hull

Current Primary Outcome: Cumulative or secondary patency [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Hull

Dates:
Date Received: July 11, 2011
Date Started: May 2012
Date Completion: October 2014
Last Updated: July 11, 2011
Last Verified: July 2011