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NCT01597115 Clinical Trial

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

End Stage Renal Disease Clinical Trial

— ENHANCE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01597115
Other study ID # DUPLEX-IV-02-12
Secondary ID
Status Completed
Phase N/A
First received May 10, 2012
Last updated May 25, 2015
Start date May 2012
Est. completion date September 2014

Study information
Verified date May 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Duplex ultrasonography

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary hemodialysis access maturation rate 8 weeks after surgery No
Secondary factors predicting maturation failure 8 weeks after surgery No
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