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Effects of On-Line Hemodiafiltration(HDF) on Vascular Health in Chronic Hemodialysis Patients

NCT ID: NCT00532597

Last Updated: 2007-09-20

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to determine whether on-line hemodiafiltration ameliorate the endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease patients on maintenance hemodialysis.

Detailed Description

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1. On-line hemodiafiltration(OL-HDF) is a technique that combines diffusion with convection in which the large substitution fluid is produced directly from the dialysate. It offers many advantages aside from its safe inflammatory profile, which is attributable to the use of ultrapure dialysate and highly biocompatible dialysis membranes. Due to an improved convective clearance, significantly increased removal of large or protein-bound uremic retention solutes can be achieved, with a potential benefit on cardiovascular morbidity and mortality.
2. Endothelial dysfunction, almost universal in end stage renal disease, is important risk factor for cardiovascular events, and can be evaluated by brachial artery endothelium-dependent vasodilation (flow-mediated dilation) to reactive hyperemia following 5 min of forearm ischemia.
3. The stable HD patients will receive 8-week treatment on OL-HDF or conventional low flux HD and then crossed over to opposite treatment arm. The FMD will be measured by one sonographer, and at the same time whole blood and serum will be sampled and stored for further analysis. The timepoint for measurement is 4-week interval after baseline evaluation.

Conditions

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End Stage Renal Disease Hemodialysis

Keywords

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Vascular Endothelium-Dependent Relaxation Hemodialysis Hemodiafiltration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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O

Group Type EXPERIMENTAL

On-line hemodiafiltration

Intervention Type PROCEDURE

L

Group Type ACTIVE_COMPARATOR

Low flux hemodialysis

Intervention Type PROCEDURE

Interventions

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On-line hemodiafiltration

Intervention Type PROCEDURE

Low flux hemodialysis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* end stage renal disease on maintenance hemodialysis for more than 3 months

Exclusion Criteria

* diagnosis of active cardiovascular diseases in 6 months
* elevation of liver enzymes over two fold of upper normal limit in 3 months
* admission for acute infection in 3 months
* untreatable stenosis of vascular access
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eulji General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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SuAh Sung, M.D.,PhD.

Role: STUDY_CHAIR

Department of Internal Medicine, College of Medicine, Eulji University

Locations

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Eulji General Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Young-Hwan Hwang, M.D.

Role: CONTACT

Phone: 82-2-970-8457

Email: [email protected]

Su-Ah Sung, M.D., PhD.

Role: CONTACT

Phone: 82-2-970-8205

Email: [email protected]

Facility Contacts

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Young-Hwan Hwang, M.D.

Role: primary

Su-Ah Sung, M.D.,PhD.

Role: backup

Other Identifiers

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EMCIRB 07-01

Identifier Type: -

Identifier Source: org_study_id