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NCT03456232 Clinical Trial

High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease

Chronic Kidney Failure Clinical Trial

Official title:
High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03456232
Other study ID # GDREC2017324H
Secondary ID
Status Recruiting
Phase N/A
First received February 27, 2018
Last updated March 5, 2018
Start date December 21, 2017
Est. completion date March 20, 2018

Study information
Verified date February 2018
Source Guangdong General Hospital
Contact Yi Li, Master
Phone +86-20-81346722
Email 13580588265@139.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self matching study, participants will receive high-flux hemodialysis compared to hemodiafiltration.

Description:

Hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water, is one of the most commonly replacement therapy.

Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date March 20, 2018
Est. primary completion date March 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria:

1. Subject has end-stage renal disease.

2. Subject has been on regular dialysis treatment for at least 6 months.

3. Subject has autologous vascular access.

4. Subject is offered thrice weekly hemodialysis.

5. Subject is offered 4 hours duration hemodialysis.

Exclusion Criteria:

1. Infectious disease

2. Poor echocardiographic window that was unsuitable for interpretation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• High-flux hemodialysis
High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.
• Hemodiafiltration
Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.

Locations
Country Name City State
China Guangdong General Hospital Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clearance of moderate molecule substance Clearance rate of b2-microglobulin for one dialysis. 4 hours after dialysis
Secondary Left ventricular ejection fraction Left ventricular ejection fraction is calculated by dividing the volume of blood pumped from the left ventricle per beat, also known as stroke volume, by the end-diastolic volume. 4 hours after dialysis
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