Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemodialysis Access Failure
• Interventions: Procedure: Arteriovenous Grafts

• Registration Number: NCT04388397
• Lead Sponsor: Egyptian Biomedical Research Network

Brief Summary

Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.

Detailed Description

The study aimed to evaluate and compare patency rate and complications of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) in end stage renal disease (ESRD) patients for one year after the intervention. Patients were randomly divided into two groups: SAVGs group and IAAVGs group. Patients with ESRD with no chance for native AVF were examined clinically and by duplex ultrasonography preoperatively. Follow up was for one year. Primary end points were the success rate, complications rate (hematoma, pseudo-aneurysm, graft site infection, systemic bacteremia), time of first cannulation. Secondary end points were primary and secondary patency within one year.

Study Timeline

• Study Start: 2017-08-15
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-14
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

• Adult hemodialysis patients

Exclusion Criteria

• Significant cardiorespiratory comorbidities.
• Peripheral vascular disease.
• Pregnancy or lactation.
• Severe bleeding disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate-access Arteriovenous Grafts	Arteriovenous Grafts	Immediate-access Arteriovenous Grafts as a vascular access for hemodialysis patients
Standard Arteriovenous Grafts	Arteriovenous Grafts	Standard Arteriovenous Grafts as a vascular access for hemodialysis patients

Primary Outcome Measures

Name	Time	Method
Success rate	24 hours	successful graft procedure
Primary Patency	1 year	Patency of hemodialysis access

Secondary Outcome Measures

Name	Time	Method
Complications rate	1 year	Any graft complications

Trial Locations

Locations (2)

Faculty of Medicine; 🇪🇬 Zagazig, Egypt

Faculty of Medicine, Zagazig University; 🇪🇬 Zagazig, Egypt