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

NCT02673099 | Completed

• 1 other identifier: 0082-13
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

HDF online; ESRD; Hemodialysis; oxidative stress; quality of life; Hemodialysis treatment

Outcome Measures

Primary Outcomes (1)

• Improvement of quality of life

  1 year

Secondary Outcomes (1)

• Oxidative stress reduction

  1 year

Study Arms (1)

HDF online

OTHER

All patients were started on HF (high-flux) hemodialysis. After 6 months they were then treated by HDF online.

Procedure: HDF online

Interventions

HDF online PROCEDURE

Hemodialysis by the HDF online method

HDF online

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On chronic hemodialysis more than 3 months

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Western Galilee Hospital

Nahariya, 22100, Israel

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2016
• First Posted: February 3, 2016
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)