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OpenTrials
Completed

NCT Number: NCT01597115

ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment

The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after surgery by duplex in all patients.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • end stage renal disease
  • newly formed hemodialysis access with native vein
  • 20~70 years

Exclusion criteria

  • hemodialysis access surgery with ePTFE graft
  • hemodialysis access surgery with basilic vein transposition
  • hemodialysis access surgery with brachial vein transposition
  • cephalic vein < 2.5mm in diameter
  • radial artery diameter <2.0mm in radiocephalic arteriovenous fistula

Treatment and study plan

Duplex ultrasonography

Procedure

Primary outcomes

  1. hemodialysis access maturation rate

    Time frame: 8 weeks after surgery

Secondary outcomes

  1. factors predicting maturation failure

    Time frame: 8 weeks after surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: ENHANCE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 11, 2012
Registry last updated
May 27, 2015

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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