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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456232
Recruitment Status : Unknown
Verified February 2018 by Guangdong Provincial People's Hospital.
Recruitment status was:  Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Failure Other: High-flux hemodialysis Other: Hemodiafiltration Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : March 10, 2018
Estimated Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High-flux hemodialysis
High-flux hemodialysis lasting for 4 hours
 Other: High-flux hemodialysis
High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.
Active Comparator: Hemodiafiltration
Hemodiafiltration lasting for 4 hours
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Clearance of moderate molecule substance [ Time Frame: 4 hours after dialysis ]
    Clearance rate of b2-microglobulin for one dialysis.


Secondary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 4 hours after dialysis ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT03456232


Contacts
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Contact: Yi Li, Master ＋86-20-81346722 13580588265@139.com

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: wei shi, MD,PhD    ＋86-20-83850849    13925056339@163.com   
Contact: Yi Li, Master    ＋86-20-81346722    13580588265@139.com   
Sub-Investigator: Yi Li, Master         
Sub-Investigator: Shuangxin Liu, MD,PhD         
Sub-Investigator: Jianchao Ma, MD,PhD         
Sub-Investigator: Lixia Xu, MD,PhD         
Sub-Investigator: Yuanhan Chen, Master         
Sub-Investigator: Ting Lin, MD,PhD         
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: Wei Shi, MD,PhD Guangdong Provincial People's Hospital
More Information
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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03456232    
Other Study ID Numbers: GDREC2017324H
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Supporting Information: study protocol, statistic analysis plan, informed consent form, clinical study report.

Time Frame: Data will be available within 1 year of study completion. Access Criteria: Data access requests will be reviewed by an external Independent Review panel. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangdong Provincial People's Hospital:
hemodialysis
hemodiafiltration
end-stage renal disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic