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

Sponsor

Eulji General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00532597

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Hemodialysis	Procedure: On-line hemodiafiltration Procedure: Low flux hemodialysis	Phase 4

Detailed Description

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.
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.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of On-Line Hemodiafiltration(HDF) on Endothelial Dysfunction in Chronic Hemodialysis Patients

Study Start Date :

Apr 1, 2007

Anticipated Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: O	Procedure: On-line hemodiafiltration
Active Comparator: L	Procedure: Low flux hemodialysis

Arm

Intervention/Treatment

Experimental: O

Procedure: On-line hemodiafiltration

Active Comparator: L

Procedure: Low flux hemodialysis

Outcome Measures

Primary Outcome Measures

endothelial dysfunction measured by flow-mediated vasodilation [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eulji General Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Eulji General Hospital

Investigators

Study Chair: SuAh Sung, M.D.,PhD., Department of Internal Medicine, College of Medicine, Eulji University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00532597

Other Study ID Numbers:

EMCIRB 07-01

First Posted:

Sep 20, 2007

Last Update Posted:

Sep 20, 2007

Last Verified:

Sep 1, 2007

Keywords provided by , ,

Vascular Endothelium-Dependent Relaxation

Hemodialysis

Hemodiafiltration

Additional relevant MeSH terms:

Kidney Failure, Chronic

Study Results

No Results Posted as of Sep 20, 2007