Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemodialysis Access Failure

Intervention / Treatment
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* Procedure: Arteriovenous Grafts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult hemodialysis patients Exclusion Criteria: Significant cardiorespiratory comorbidities. Peripheral vascular disease. Pregnancy or lactation. Severe bleeding disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate-access Arteriovenous Grafts<br>Immediate-access Arteriovenous Grafts as a vascular access for hemodialysis patients | Procedure: Arteriovenous Grafts<br>* 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.<br>|
| Active Comparator: Standard Arteriovenous Grafts<br>Standard Arteriovenous Grafts as a vascular access for hemodialysis patients | Procedure: Arteriovenous Grafts<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Patency of hemodialysis access | 1 year | 
| Success rate | successful graft procedure | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications rate | Any graft complications | 1 year |