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NCT04388397 Clinical Trial

Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients

Hemodialysis Access Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04388397
Other study ID # 02090520
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2017
Est. completion date April 10, 2020

Study information
Verified date July 2020
Source Egyptian Biomedical Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 477
Est. completion date April 10, 2020
Est. primary completion date April 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Adult hemodialysis patients

Exclusion Criteria:

- Significant cardiorespiratory comorbidities.

- Peripheral vascular disease.

- Pregnancy or lactation.

- Severe bleeding disorders.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Arteriovenous Grafts
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.

Locations
Country Name City State
Egypt Faculty of Medicine Zagazig
Egypt Faculty of Medicine, Zagazig University Zagazig

Sponsors (1)
Lead Sponsor Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Patency Patency of hemodialysis access 1 year
Primary Success rate successful graft procedure 24 hours
Secondary Complications rate Any graft complications 1 year
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