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

NCT04098159 | Unknown

• 1 other identifier: Surveillance of an A-V access
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hemodialysis Access Failure

Outcome Measures

Primary Outcomes (1)

• Number, type and technical success rate for elective interventions

  within one year of creation of the VA

Secondary Outcomes (3)

• 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

Study Arms (1)

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

EXPERIMENTAL

Device: duplex ultrasound

Interventions

duplex ultrasound DEVICE

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

Also known as: diagnostic venography, angioplasty, surgery

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 10584659 BACKGROUND

• 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.

  PMID: 21906166 BACKGROUND

• 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.

  PMID: 11904577 BACKGROUND

• 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.

  PMID: 8172208 BACKGROUND

• 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.

  PMID: 17507428 BACKGROUND

• 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.

  PMID: 10965064 BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler, Duplex; Angioplasty; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

ahmed m rashed, resident

CONTACT

00201064252719; ahmedrashed9933@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of vascular surgery

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: July 1, 2021
• Last Updated: September 24, 2019

Record last verified: 2019-09