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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532597
Recruitment Status : Unknown
Verified September 2007 by Eulji General Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2007
Last Update Posted : September 20, 2007
Information provided by:
Eulji General Hospital

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:
  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.

Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2007
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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

Primary Outcome Measures :
  1. endothelial dysfunction measured by flow-mediated vasodilation [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00532597

Contact: Young-Hwan Hwang, M.D. 82-2-970-8457
Contact: Su-Ah Sung, M.D., PhD. 82-2-970-8205

Korea, Republic of
Eulji General Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young-Hwan Hwang, M.D.    82-2-970-8457   
Contact: Su-Ah Sung, M.D.,PhD.    82-2-970-8205   
Sponsors and Collaborators
Eulji General Hospital
Study Chair: SuAh Sung, M.D.,PhD. Department of Internal Medicine, College of Medicine, Eulji University Identifier: NCT00532597     History of Changes
Other Study ID Numbers: EMCIRB 07-01
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: September 2007

Keywords provided by Eulji General Hospital:
Vascular Endothelium-Dependent Relaxation

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases