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

Study Overview
=================
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.

Official Title
-----------------
Effects of On-Line Hemodiafiltration(HDF) on Endothelial Dysfunction in Chronic Hemodialysis Patients

Conditions
-----------------
End Stage Renal Disease, Hemodialysis

Intervention / Treatment
-----------------
* Procedure: On-line hemodiafiltration
* Procedure: Low flux hemodialysis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: O<br> | Procedure: On-line hemodiafiltration<br> <br> |
| Active Comparator: L<br> | Procedure: Low flux hemodialysis<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial dysfunction measured by flow-mediated vasodilation |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular Endothelium-Dependent Relaxation, Hemodialysis, Hemodiafiltration