ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
ENHANCE
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 27, 2015
May 1, 2014
2.3 years
May 10, 2012
May 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemodialysis access maturation rate
8 weeks after surgery
Secondary Outcomes (1)
factors predicting maturation failure
8 weeks after surgery
Study Arms (2)
Duplex
ACTIVE COMPARATORPatients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery
physical exam
NO INTERVENTIONAccording to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery
Interventions
Eligibility Criteria
You may qualify if:
- end stage renal disease
- newly formed hemodialysis access with native vein
- \~70 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Il Min, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2012
First Posted
May 11, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 27, 2015
Record last verified: 2014-05