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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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ClinicalTrials.gov Identifier: NCT02673099
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Western Galilee Hospital-Nahariya

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Procedure: HDF online Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
HDF online
All patients were started on HF (high-flux) hemodialysis. After 6 months they were then treated by HDF online.
Procedure: HDF online
Hemodialysis by the HDF online method




Primary Outcome Measures :
  1. Improvement of quality of life [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Oxidative stress reduction [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On chronic hemodialysis more than 3 months

Exclusion Criteria:

  • No exclusions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673099


Locations
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Israel
Western Galilee Hospital
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
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Responsible Party: Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT02673099    
Other Study ID Numbers: 0082-13
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Western Galilee Hospital-Nahariya:
HDF online
ESRD
Hemodialysis
oxidative stress
quality of life
Hemodialysis treatment
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency