Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access

Hemodialysis Access Failure Clinical Trial

Official title:

Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04098159
• Other study ID #: Surveillance of an A-V access
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: ahmed m rashed, resident
• Phone: 00201064252719
• Email: ahmedrashed9933[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Kidney disease (CKD) is a worldwide public health problem that classified into five stages (1). End stage renal disease (CDK stage 5) patients require a well-functioning vascular access (VA) for successful hemodialysis treatment (2). Types of VA include arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs). A vascular access is liable to early or late complications, and ultimately access failure. A meta-analysis showed that a 17% mean early access failure However recent studies have shown higher failure rates of up to 46%, with one year patencies between 52% to 83% (3). Low VA flow, thrombosis and loss of patency may result in under-dialysis that leads to increased morbidity, mortality and healthcare expenditure (4). In the majority of VAs, stenoses develop over variable intervals causing VA thrombosis and failure (5). If early detected and corrected, VA function and patency can be preserved and under-dialysis can be minimized or avoided. The aim of this study is to find out the role of periodic surveillance of VA in the detection of VA dysfunction and correctable lesions that may necessitate pre-emptive interventions to maintain VA patency and prevent VA loss

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ESRD Patients have functioning or failing VAs (AVFs or AVGs).

Exclusion Criteria:

• ESRD patients have infected or failed VAs .

• patientrefusal .

Related Conditions & MeSH terms

• Hemodialysis Access Failure

Intervention

Device:
• duplex ultrasound
regular duplex follow up every three months with subsequent intervention either diagnostic venography , angioplasty or surgery according to the type of the lesion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Besarab A. Advances in end-stage renal diseases 2000. Access monitoring methods. Blood Purif. 2000;18(4):255-9. Review. — View Citation

Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. Technology Assessment Committee. J Vasc Interv Radiol. 1999 Nov-Dec;10(10):1405-15. Review. — View Citation

Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose of dialysis on morbidity and mortality. Am J Kidney Dis. 1994 May;23(5):661-9. — View Citation

Lee T, Mokrzycki M, Moist L, Maya I, Vazquez M, Lok CE; North American Vascular Access Consortium. Standardized definitions for hemodialysis vascular access. Semin Dial. 2011 Sep-Oct;24(5):515-24. doi: 10.1111/j.1525-139X.2011.00969.x. Epub 2011 Sep 9. Review. — View Citation

National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. — View Citation

Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, type and technical success rate for elective interventions		within one year of creation of the VA
Secondary	secondary patency rate of the Arteriovenous Access after elective intervention		within one year of creation of the VA
Secondary	number , type of complication that resulted from elective interventions		within one year of creation of the VA
Secondary	primary patency rate of newly created Arteriovenous Access in assiut governorate		within one year of creation of the VA