search
Back to results

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

Primary Purpose

Chronic Kidney Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-flux hemodialysis
Hemodiafiltration
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring hemodialysis, hemodiafiltration, end-stage renal disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-flux hemodialysis

Hemodiafiltration

Arm Description

High-flux hemodialysis lasting for 4 hours

Hemodiafiltration lasting for 4 hours

Outcomes

Primary Outcome Measures

Clearance of moderate molecule substance
Clearance rate of b2-microglobulin for one dialysis.

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2018
Last Updated
March 5, 2018
Sponsor
Guangdong Provincial People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03456232
Brief Title
High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
Official Title
High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
March 10, 2018 (Anticipated)
Study Completion Date
March 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
hemodialysis, hemodiafiltration, end-stage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-flux hemodialysis
Arm Type
Experimental
Arm Description
High-flux hemodialysis lasting for 4 hours
Arm Title
Hemodiafiltration
Arm Type
Active Comparator
Arm Description
Hemodiafiltration lasting for 4 hours
Intervention Type
Other
Intervention Name(s)
High-flux hemodialysis
Intervention Description
High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.
Intervention Type
Other
Intervention Name(s)
Hemodiafiltration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clearance of moderate molecule substance
Description
Clearance rate of b2-microglobulin for one dialysis.
Time Frame
4 hours after dialysis
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
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.
Time Frame
4 hours after dialysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject has end-stage renal disease. Subject has been on regular dialysis treatment for at least 6 months. Subject has autologous vascular access. Subject is offered thrice weekly hemodialysis. Subject is offered 4 hours duration hemodialysis. Exclusion Criteria: Infectious disease Poor echocardiographic window that was unsuitable for interpretation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Li, Master
Phone
＋86-20-81346722
Email
13580588265@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Shi, MD,PhD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei shi, MD,PhD
Phone
＋86-20-83850849
Email
13925056339@163.com
First Name & Middle Initial & Last Name & Degree
Yi Li, Master
Phone
＋86-20-81346722
Email
13580588265@139.com
First Name & Middle Initial & Last Name & Degree
Yi Li, Master
First Name & Middle Initial & Last Name & Degree
Shuangxin Liu, MD,PhD
First Name & Middle Initial & Last Name & Degree
Jianchao Ma, MD,PhD
First Name & Middle Initial & Last Name & Degree
Lixia Xu, MD,PhD
First Name & Middle Initial & Last Name & Degree
Yuanhan Chen, Master
First Name & Middle Initial & Last Name & Degree
Ting Lin, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs