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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:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01597115
First received: May 10, 2012
Last updated: November 17, 2014
Last verified: November 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • factors predicting maturation failure [ Time Frame: 8 weeks after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01597115     History of Changes
Other Study ID Numbers: DUPLEX-IV-02-12
Study First Received: May 10, 2012
Last Updated: November 17, 2014
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014