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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arteriovenous Fistula, Tourniquet, Stenosis

Intervention / Treatment
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* Other: Tourniquet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Vascular clamps<br>Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol). | |
| Experimental: Tourniquet<br>Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery. | Other: Tourniquet<br>* A tourniquet will be used during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stenosis postoperative (duplex ultrasonography) | Luminal vessel diameter | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | Duration of surgery in minutes | During surgery | 
| AVF occlusion | AVF occlusion | Within 3 months after surgery | 
| Bleeding | Bleeding | Within 3 months after surgery | 
| Infection | Infection | Within 3 months after surgery | 
| Pseudoaneurysm | Pseudoaneurysm | Within 3 months after surgery | 
| Need for reintervention | Surgical or endovascular reintervention | 1 year postoperative |