Effects of On-Line Hemodiafiltration(HDF) on Vascular Health in Chronic Hemodialysis Patients
Primary Purpose
End Stage Renal Disease, Hemodialysis
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
On-line hemodiafiltration
Low flux hemodialysis
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Vascular Endothelium-Dependent Relaxation, Hemodialysis, Hemodiafiltration
Eligibility 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
Sites / Locations
- Eulji General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
O
L
Arm Description
Outcomes
Primary Outcome Measures
endothelial dysfunction measured by flow-mediated vasodilation
Secondary Outcome Measures
Full Information
NCT ID
NCT00532597
First Posted
September 19, 2007
Last Updated
September 19, 2007
Sponsor
Eulji General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00532597
Brief Title
Effects of On-Line Hemodiafiltration(HDF) on Vascular Health in Chronic Hemodialysis Patients
Official Title
Effects of On-Line Hemodiafiltration(HDF) on Endothelial Dysfunction in Chronic Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Eulji General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis
Keywords
Vascular Endothelium-Dependent Relaxation, Hemodialysis, Hemodiafiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
O
Arm Type
Experimental
Arm Title
L
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
On-line hemodiafiltration
Intervention Type
Procedure
Intervention Name(s)
Low flux hemodialysis
Primary Outcome Measure Information:
Title
endothelial dysfunction measured by flow-mediated vasodilation
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Hwan Hwang, M.D.
Phone
82-2-970-8457
Email
ondahl@eulji.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Su-Ah Sung, M.D., PhD.
Phone
82-2-970-8205
Email
soi@eulji.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SuAh Sung, M.D.,PhD.
Organizational Affiliation
Department of Internal Medicine, College of Medicine, Eulji University
Official's Role
Study Chair
Facility Information:
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Hwan Hwang, M.D.
Phone
82-2-970-8457
Email
ondahl@eulji.ac.kr
First Name & Middle Initial & Last Name & Degree
Su-Ah Sung, M.D.,PhD.
Phone
82-2-970-8205
Email
soi@eulji.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Effects of On-Line Hemodiafiltration(HDF) on Vascular Health in Chronic Hemodialysis Patients
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