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NCT Number: NCT04388397

Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients

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.

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Key information

Conditions

Hemodialysis Access Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Zagazig, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult hemodialysis patients

Exclusion criteria

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

Treatment and study plan

Arteriovenous Grafts

Procedure

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.

Primary outcomes

  1. Primary Patency

    Time frame: 1 year

    Patency of hemodialysis access

  2. Success rate

    Time frame: 24 hours

    successful graft procedure

Secondary outcomes

  1. Complications rate

    Time frame: 1 year

    Any graft complications

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 14, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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