Back to resultsENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment (ENHANCE)
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Duplex ultrasonography
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring duplex study, hemodialysis access, maturation rate, endovascular intervention
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Duplex
physical exam
Arm Description
Patients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery
According to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery
Outcomes
Primary Outcome Measures
hemodialysis access maturation rate
Secondary Outcome Measures
factors predicting maturation failure
Full Information
NCT ID
NCT01597115
First Posted
May 10, 2012
Last Updated
May 25, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01597115
Brief Title
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
Acronym
ENHANCE
Official Title
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
duplex study, hemodialysis access, maturation rate, endovascular intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duplex
Arm Type
Active Comparator
Arm Description
Patients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery
Arm Title
physical exam
Arm Type
No Intervention
Arm Description
According to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery
Intervention Type
Procedure
Intervention Name(s)
Duplex ultrasonography
Primary Outcome Measure Information:
Title
hemodialysis access maturation rate
Time Frame
8 weeks after surgery
Secondary Outcome Measure Information:
Title
factors predicting maturation failure
Time Frame
8 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Il Min, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
We'll reach out to this number within 24 hrs