High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2017
CompletedFirst Submitted
Initial submission to the registry
February 27, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2018
CompletedMarch 7, 2018
February 1, 2018
3 months
February 27, 2018
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clearance of moderate molecule substance
Clearance rate of b2-microglobulin for one dialysis.
4 hours after dialysis
Secondary Outcomes (1)
Left ventricular ejection fraction
4 hours after dialysis
Study Arms (2)
High-flux hemodialysis
EXPERIMENTALHigh-flux hemodialysis lasting for 4 hours
Hemodiafiltration
ACTIVE COMPARATORHemodiafiltration lasting for 4 hours
Interventions
High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Infectious disease
- Poor echocardiographic window that was unsuitable for interpretation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Shi, MD,PhD
Guangdong Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2018
First Posted
March 7, 2018
Study Start
December 21, 2017
Primary Completion
March 10, 2018
Study Completion
March 20, 2018
Last Updated
March 7, 2018
Record last verified: 2018-02