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

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

Study Overview

• Status: Unknown
• Conditions: Hemodialysis Access Failure
• Intervention / Treatment: Device: duplex ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed m rashed, resident; Phone Number: 00201064252719; Email: ahmedrashed9933@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESRD Patients have functioning or failing VAs (AVFs or AVGs).	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; Other Names: surgery; angioplasty; diagnostic venography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number, type and technical success rate for elective interventions	within one year of creation of the VA

Secondary Outcome Measures

Outcome Measure	Time Frame
secondary patency rate of the Arteriovenous Access after elective intervention	within one year of creation of the VA
number , type of complication that resulted from elective interventions	within one year of creation of the VA
primary patency rate of newly created Arteriovenous Access in assiut governorate	within one year of creation of the VA

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1016/s1051-0443(99)70252-6. No abstract available.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 21, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Surveillance of an A-V access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No