The Benefit of Оn-Line High Convection Volume Hemodiafiltration Treatment Versus High Flow Dialysis on Reduction of Oxidative Stress and Health Related Quality of Life in Dialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HDF online
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring HDF online, ESRD, Hemodialysis, oxidative stress, quality of life, Hemodialysis treatment
Eligibility Criteria
Inclusion Criteria:
- On chronic hemodialysis more than 3 months
Exclusion Criteria:
- No exclusions
Sites / Locations
- Western Galilee Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HDF online
Arm Description
All patients were started on HF (high-flux) hemodialysis. After 6 months they were then treated by HDF online.
Outcomes
Primary Outcome Measures
Improvement of quality of life
Secondary Outcome Measures
Oxidative stress reduction
Full Information
NCT ID
NCT02673099
First Posted
January 30, 2016
Last Updated
May 8, 2017
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT02673099
Brief Title
The Benefit of Оn-Line High Convection Volume Hemodiafiltration Treatment Versus High Flow Dialysis on Reduction of Oxidative Stress and Health Related Quality of Life in Dialysis Patients
Official Title
The Benefit of Оn-Line High Convection Volume Hemodiafiltration Treatment Versus High Flow Dialysis on Reduction of Oxidative Stress and Health Related Quality of Life in Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: Patients with end stage renal disease are exposed to metabolic and hemodynamic complications due to the disease itself and as a result of the dialysis treatment related complications. Uremic toxins due to their middle molecular weight are not effectively removed during Hemodialysis. Their accumulation leads to chronic oxidative stress and chronic inflammation state associated with increased morbidity and mortality. In addition, during each dialysis session oxidative stress (OS) and inflammation are provoked once blood interacts with the dialyzer.
In recent years the use of Online Hemodiafiltration (OL- HDF) has entered in order to enable better uremic toxins clearance. This a relatively new method of therapy that allows a larger volume of blood filtration during a single dialysis therapy compared with standard hemodialysis. It combines diffusion with convection to clear middle molecular weight substances more effectively compared with Hemodialysis. This method was found to reduce rates of cardiovascular morbidity and mortality among dialysis patients.
Detailed Description
The purpose of this study is to examine whether dialysis by high convection volume OL HDF reduces oxidative stress and inflammation levels, improving hemodynamic stability and metabolic complications compared to dialysis with High Flux (HF) membranes.
Methods: After a rush in period of 3 month with HF membranes, 45 dialysis patients were treated with HF for 6 months and then converted to 6 months of OL HDF treatment. The hemodynamic stability was measured during treatment throughout all the study and Quality of life was assessed by a reliable and valid tool developed and adapted specifically for ESRD population according to Kidney Disease Quality of Life Short Form (KDQOL- SF).
We propose to measure biomarkers of inflammation and oxidative stress in all blood samples collected at the end of each period for the following ( The number of blood samples to be analyzed: 45 patients 3 samples per patient total of 135 samples ).
Total glycated proteins in relation to total proteins and to oncotic pressure of the samples. We have shown that the oncotic pressure can serve as a better measure of albumin concentrations than the albumin measured in routine clinical laboratories3.
Albumin detection index4 and levels of albumin, as a measure of oxidation and inflammation (negative acute phase protein).
Levels of Beta2m.
Levels of Klotho: It was shown that reduced serum soluble Klotho is associated with all-cause mortality, even after adjusting for confounding variables, implying that the level of serum soluble Klotho plays a role as a predictive indicator of overall mortality in patients with ESRD.
Levels of myeloperoxidase (MPO), a products of neutrophils degranulation due to activation by the dialysis treatment.
Oxidation reduction potential (ORP), a global measure of all oxidant and antioxidant activity (A new instrument introduced in our research laboratory)
Advanced oxidation protein products (AOPP) , a measure of total protein oxidation
Implication: The study will examine whether OL-HDF dialysis with high convection volume is associated with a reduction of oxidative stress and inflammation markers and improvement in the quality of life of dialysis patients. The results of this study will encourage the use of this new treatment mode in order to reduce the high morbidity resulting from OS and inflammation among these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
HDF online, ESRD, Hemodialysis, oxidative stress, quality of life, Hemodialysis treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HDF online
Arm Type
Other
Arm Description
All patients were started on HF (high-flux) hemodialysis. After 6 months they were then treated by HDF online.
Intervention Type
Procedure
Intervention Name(s)
HDF online
Intervention Description
Hemodialysis by the HDF online method
Primary Outcome Measure Information:
Title
Improvement of quality of life
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Oxidative stress reduction
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On chronic hemodialysis more than 3 months
Exclusion Criteria:
No exclusions
Facility Information:
Facility Name
Western Galilee Hospital
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Benefit of Оn-Line High Convection Volume Hemodiafiltration Treatment Versus High Flow Dialysis on Reduction of Oxidative Stress and Health Related Quality of Life in Dialysis Patients
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