Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients

Egyptian Biomedical Research Network

Status: Completed

Conditions: Hemodialysis Access Failure

Treatments: Procedure: Arteriovenous Grafts

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04388397

02090520

Details and patient eligibility

About

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.

Full 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.

Enrollment: 477 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult hemodialysis patients

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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477 participants in 2 patient groups

Immediate-access Arteriovenous Grafts

Experimental group

Description:

Immediate-access Arteriovenous Grafts as a vascular access for hemodialysis patients

Treatment:

Procedure: Arteriovenous Grafts

Standard Arteriovenous Grafts

Active Comparator group

Description:

Standard Arteriovenous Grafts as a vascular access for hemodialysis patients

Treatment:

Procedure: Arteriovenous Grafts