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

Arteriovenous Fistula Clinical Trial

— ABAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04402775
• Other study ID #: NL54827.098.15
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: July 2018

Study information

• Verified date: May 2020
• Source: HagaZiekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Constriction, Pathologic
• Fistula
• Stenosis
• Tourniquet

Intervention

Other:
• Tourniquet
A tourniquet will be used during surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HagaZiekenhuis

References & Publications (10)

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. — View Citation

Biuckians A, Scott EC, Meier GH, Panneton JM, Glickman MH. The natural history of autologous fistulas as first-time dialysis access in the KDOQI era. J Vasc Surg. 2008 Feb;47(2):415-21; discussion 420-1. doi: 10.1016/j.jvs.2007.10.041. — View 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. — View 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. — View Citation

Hodges TC, Fillinger MF, Zwolak RM, Walsh DB, Bech F, Cronenwett JL. Longitudinal comparison of dialysis access methods: risk factors for failure. J Vasc Surg. 1997 Dec;26(6):1009-19. — View Citation

Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.

Turmel-Rodrigues L, Boutin JM, Camiade C, Brillet G, Fodil-Chérif 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. — View Citation

Turmel-Rodrigues L, Mouton A, Birmelé B, Billaux L, Ammar N, Grézard O, Hauss S, Pengloan J. Salvage of immature forearm fistulas for haemodialysis by interventional radiology. Nephrol Dial Transplant. 2001 Dec;16(12):2365-71. — View Citation

Vascular Access 2006 Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S176-247. — View Citation

Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stenosis postoperative (duplex ultrasonography)	Luminal vessel diameter	6 weeks
Secondary	Duration of surgery	Duration of surgery in minutes	During surgery
Secondary	AVF occlusion	AVF occlusion	Within 3 months after surgery
Secondary	Bleeding	Bleeding	Within 3 months after surgery
Secondary	Infection	Infection	Within 3 months after surgery
Secondary	Pseudoaneurysm	Pseudoaneurysm	Within 3 months after surgery
Secondary	Need for reintervention	Surgical or endovascular reintervention	1 year postoperative