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Clinical Trials/NCT04402775
NCT04402775
Terminated
N/A

Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.

HagaZiekenhuis0 sites25 target enrollmentApril 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arteriovenous Fistula
Sponsor
HagaZiekenhuis
Enrollment
25
Primary Endpoint
Stenosis postoperative (duplex ultrasonography)
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.

Detailed Description

Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
July 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

M.J.C. de Kok

Medical student

HagaZiekenhuis

Eligibility Criteria

Inclusion Criteria

  • Mentally competent
  • Written informed consent
  • Age 18 years and older
  • Indication for brachiocephalic AVF in HagaZiekenhuis
  • Patient is able to complete the follow-up evaluation

Exclusion Criteria

  • Pregnancy

Outcomes

Primary Outcomes

Stenosis postoperative (duplex ultrasonography)

Time Frame: 6 weeks

Luminal vessel diameter

Secondary Outcomes

  • AVF occlusion(Within 3 months after surgery)
  • Bleeding(Within 3 months after surgery)
  • Infection(Within 3 months after surgery)
  • Need for reintervention(1 year postoperative)
  • Duration of surgery(During surgery)
  • Pseudoaneurysm(Within 3 months after surgery)

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