Clinical trial NCT04402775: Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
Official title: Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arteriovenous Fistula
Tourniquet
Stenosis
Lead sponsor: HagaZiekenhuis
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Stenosis postoperative (duplex ultrasonography)
timeFrame: 6 weeks
Secondary outcomes:
measure: Duration of surgery
timeFrame: During surgery
measure: AVF occlusion
timeFrame: Within 3 months after surgery
measure: Bleeding
timeFrame: Within 3 months after surgery
measure: Infection
timeFrame: Within 3 months after surgery
measure: Pseudoaneurysm
timeFrame: Within 3 months after surgery
measure: Need for reintervention
timeFrame: 1 year postoperative
Other outcomes:
Locations:
Study officials:
References:
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citation: Duijm LE, Overbosch EH, Liem YS, Planken RN, Tordoir JH, Cuypers PW, Douwes-Draaijer P, de Haan MW. Retrograde catheterization of haemodialysis fistulae and grafts: angiographic depiction of the entire vascular access tree and stenosis treatment. Nephrol Dial Transplant. 2009 Feb;24(2):539-47. doi: 10.1093/ndt/gfn526. Epub 2008 Sep 18.
citation: Beathard GA, Arnold P, Jackson J, Litchfield T; Physician Operators Forum of RMS Lifeline. Aggressive treatment of early fistula failure. Kidney Int. 2003 Oct;64(4):1487-94. doi: 10.1046/j.1523-1755.2003.00210.x.
citation: Turmel-Rodrigues L, Boutin JM, Camiade C, Brillet G, Fodil-Cherif M, Mouton A. Percutaneous dilation of the radial artery in nonmaturing autogenous radial-cephalic fistulas for haemodialysis. Nephrol Dial Transplant. 2009 Dec;24(12):3782-8. doi: 10.1093/ndt/gfp324. Epub 2009 Jul 1.
citation: Grogan J, Castilla M, Lozanski L, Griffin A, Loth F, Bassiouny H. Frequency of critical stenosis in primary arteriovenous fistulae before hemodialysis access: should duplex ultrasound surveillance be the standard of care? J Vasc Surg. 2005 Jun;41(6):1000-6. doi: 10.1016/j.jvs.2005.02.019.
citation: Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.