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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04098159
Collaborator
(none)
200
1
20

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: duplex ultrasound
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2020
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

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:
  • diagnostic venography
  • angioplasty
  • surgery
  • Outcome Measures

    Primary Outcome Measures

    1. Number, type and technical success rate for elective interventions [within one year of creation of the VA]

    Secondary Outcome Measures

    1. secondary patency rate of the Arteriovenous Access after elective intervention [within one year of creation of the VA]

    2. number , type of complication that resulted from elective interventions [within one year of creation of the VA]

    3. primary patency rate of newly created Arteriovenous Access in assiut governorate [within one year of creation of the VA]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • ESRD Patients have functioning or failing VAs (AVFs or AVGs).
    Exclusion Criteria:
    • ESRD patients have infected or failed VAs .

    • patientrefusal .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Mohammed Rashed, resident of vascular surgery, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04098159
    Other Study ID Numbers:
    • Surveillance of an A-V access
    First Posted:
    Sep 23, 2019
    Last Update Posted:
    Sep 24, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 24, 2019