Arteriovenous Fistula, Stenosis, Tourniquet
Conditions
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.
Interventions
OTHERTourniquet
A tourniquet will be used during surgery
Sponsors
HagaZiekenhuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stenosis postoperative (duplex ultrasonography) | 6 weeks | Luminal vessel diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AVF occlusion | Within 3 months after surgery | AVF occlusion |
| Bleeding | Within 3 months after surgery | Bleeding |
| Duration of surgery | During surgery | Duration of surgery in minutes |
| Pseudoaneurysm | Within 3 months after surgery | Pseudoaneurysm |
| Need for reintervention | 1 year postoperative | Surgical or endovascular reintervention |
| Infection | Within 3 months after surgery | Infection |
Outcome results
None listed