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

March 5, 2018 updated by: Guangdong Provincial People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong General Hospital
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance of moderate molecule substance
Time Frame: 4 hours after dialysis
Clearance rate of b2-microglobulin for one dialysis.
4 hours after dialysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 hours after dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2017

Primary Completion (ANTICIPATED)

March 10, 2018

Study Completion (ANTICIPATED)

March 20, 2018

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDREC2017324H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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