Clinical trial NCT04098159: Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access
Official title: Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Access Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ESRD patients have infected or failed VAs .
* patientrefusal .

Primary outcomes:
measure: Number, type and technical success rate for elective interventions
timeFrame: within one year of creation of the VA
Secondary outcomes:
measure: secondary patency rate of the Arteriovenous Access after elective intervention
timeFrame: within one year of creation of the VA
measure: number , type of complication that resulted from elective interventions
timeFrame: within one year of creation of the VA
measure: primary patency rate of newly created Arteriovenous Access in assiut governorate
timeFrame: within one year of creation of the VA
Other outcomes:
Locations:
Study officials:
References:
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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.
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. No abstract available.
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. doi: 10.1016/s0272-6386(12)70276-7.
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. doi: 10.1093/ndt/gfm021. No abstract available.
citation: Besarab A. Advances in end-stage renal diseases 2000. Access monitoring methods. Blood Purif. 2000;18(4):255-9. doi: 10.1159/000014445. No abstract available.