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
Recruitment status was Recruiting
Sponsor:
Eulji General Hospital
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
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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:
- 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.
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
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 May 16, 2013