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

Seoul National University

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Procedure: Duplex ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT01597115

DUPLEX-IV-02-12

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Duplex

Active Comparator group

Description:

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

Treatment:

Procedure: Duplex ultrasonography

physical exam

No Intervention group

Description:

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