Skip to main content
Clinical Trials/NCT04388397
NCT04388397
Completed
Not Applicable

Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients: A Randomized Clinical Study

Egyptian Biomedical Research Network2 sites in 1 country477 target enrollmentAugust 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodialysis Access Failure
Sponsor
Egyptian Biomedical Research Network
Enrollment
477
Locations
2
Primary Endpoint
Success rate
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2017
End Date
April 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Egyptian Biomedical Research Network
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult hemodialysis patients

Exclusion Criteria

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

Outcomes

Primary Outcomes

Success rate

Time Frame: 24 hours

successful graft procedure

Primary Patency

Time Frame: 1 year

Patency of hemodialysis access

Secondary Outcomes

  • Complications rate(1 year)

Study Sites (2)

Loading locations...

Similar Trials