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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Eulji General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eulji General Hospital
ClinicalTrials.gov Identifier:
NCT00532597
First received: September 19, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00532597     History of Changes
Other Study ID Numbers: EMCIRB 07-01
Study First Received: September 19, 2007
Last Updated: September 19, 2007
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014