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

NCT ID: NCT01597115

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Duplex

Patients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery

Group Type ACTIVE_COMPARATOR

Duplex ultrasonography

Intervention Type PROCEDURE

physical exam

According to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Duplex ultrasonography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang-Il Min, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DUPLEX-IV-02-12

Identifier Type: -

Identifier Source: org_study_id

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