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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597115
First Posted: May 11, 2012
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seoul National University Hospital
  Purpose
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.

Condition Intervention
End Stage Renal Disease Procedure: Duplex ultrasonography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • hemodialysis access maturation rate [ Time Frame: 8 weeks after surgery ]

Secondary Outcome Measures:
  • factors predicting maturation failure [ Time Frame: 8 weeks after surgery ]

Enrollment: 150
Study Start Date: May 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Duplex
Patients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery
Procedure: Duplex ultrasonography
No Intervention: physical exam
According to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597115


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sang-Il Min, MD Seoul National University Hospital
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01597115     History of Changes
Other Study ID Numbers: DUPLEX-IV-02-12
First Submitted: May 10, 2012
First Posted: May 11, 2012
Last Update Posted: May 27, 2015
Last Verified: May 2014

Keywords provided by Seoul National University Hospital:
duplex study
hemodialysis access
maturation rate
endovascular intervention

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases