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

Not Applicable

• Conditions: Hemodialysis Access Failure
• Interventions: Device: duplex ultrasound

• Registration Number: NCT04098159
• Lead Sponsor: Assiut University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Last Update Submitted: 2019-09-21
• Study First Posted: 2019-09-23
• Last Update Posted: 2019-09-24
• Study Start: 2019-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESRD Patients have functioning or failing VAs (AVFs or AVGs).	duplex ultrasound	-

Primary Outcome Measures

Name	Time	Method
Number, type and technical success rate for elective interventions	within one year of creation of the VA

Secondary Outcome Measures

Name	Time	Method
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