Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Access Failure
• Intervention / Treatment: Procedure: Arteriovenous Grafts

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 Type: Interventional
• Enrollment (Actual): 477
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Faculty of medicine, Zagazig university
  • Zagazig, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult hemodialysis patients

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate-access Arteriovenous Grafts; Immediate-access Arteriovenous Grafts as a vascular access for hemodialysis patients	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.
Active Comparator: Standard Arteriovenous Grafts; Standard Arteriovenous Grafts as a vascular access for hemodialysis patients	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Egyptian Biomedical Research Network
• Investigators: Principal Investigator: Ahmed Tawfik, PhD, Faculty of medicine, Zagazig university

Publications and helpful links

General Publications

• Tawfik AM, Zidan MH, Salem A, Salem A. A randomized controlled study of early versus standard cannulation of arteriovenous grafts in hemodialysis patients. J Vasc Surg. 2022 Mar;75(3):1047-1053. doi: 10.1016/j.jvs.2021.08.106. Epub 2021 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): April 10, 2020

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 02090520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No