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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Eulji General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00532597
First Posted: September 20, 2007
Last Update Posted: October 12, 2017
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.
Information provided by:
Eulji General Hospital
  Purpose
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 Intervention Phase
End Stage Renal Disease Hemodialysis Procedure: On-line hemodiafiltration Procedure: Low flux hemodialysis Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eulji General Hospital:

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

Estimated Enrollment: 20
Study Start Date: April 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: O Procedure: On-line hemodiafiltration
Active Comparator: L Procedure: Low flux hemodialysis

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.
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00532597


Contacts
Contact: Young-Hwan Hwang, M.D. 82-2-970-8457 ondahl@eulji.ac.kr
Contact: Su-Ah Sung, M.D., PhD. 82-2-970-8205 soi@eulji.ac.kr

Locations
Korea, Republic of
Eulji General Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young-Hwan Hwang, M.D.    82-2-970-8457    ondahl@eulji.ac.kr   
Contact: Su-Ah Sung, M.D.,PhD.    82-2-970-8205    soi@eulji.ac.kr   
Sponsors and Collaborators
Eulji General Hospital
Investigators
Study Chair: SuAh Sung, M.D.,PhD. Department of Internal Medicine, College of Medicine, Eulji University
  More Information

ClinicalTrials.gov Identifier: NCT00532597     History of Changes
Other Study ID Numbers: EMCIRB 07-01
First Submitted: September 19, 2007
First Posted: September 20, 2007
Last Update Posted: October 12, 2017
Last Verified: September 2007

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

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