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

Not Applicable

Terminated

• Conditions: Arteriovenous Fistula; Stenosis; Tourniquet
• Interventions: Other: Tourniquet

• Registration Number: NCT04402775
• Lead Sponsor: HagaZiekenhuis

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-16
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-24
• Last Update Submitted: 2020-05-24
• Study First Posted: 2020-05-27
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tourniquet	Tourniquet	Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.

Primary Outcome Measures

Name	Time	Method
Stenosis postoperative (duplex ultrasonography)	6 weeks	Luminal vessel diameter

Secondary Outcome Measures

Name	Time	Method
AVF occlusion	Within 3 months after surgery	AVF occlusion
Bleeding	Within 3 months after surgery	Bleeding
Infection	Within 3 months after surgery	Infection
Need for reintervention	1 year postoperative	Surgical or endovascular reintervention
Duration of surgery	During surgery	Duration of surgery in minutes
Pseudoaneurysm	Within 3 months after surgery	Pseudoaneurysm