CClinicalTrials.gg
Status unknownNCT03456232Updated Mar 7, 2018

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

An interventional study of High-flux hemodialysis and Hemodiafiltration in Chronic Kidney Failure, sponsored by Guangdong Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Kidney Failure

Keywords

  • hemodialysis
  • hemodiafiltration
  • end-stage renal disease
03

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Infectious disease
  2. Poor echocardiographic window that was unsuitable for interpretation
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    High-flux hemodialysis

    High-flux hemodialysis lasting for 4 hours

    Other: High-flux hemodialysis

  • Active comparator
    Hemodiafiltration

    Hemodiafiltration lasting for 4 hours

    Other: Hemodiafiltration

Interventions

  • OtherHigh-flux hemodialysis

    High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.

  • OtherHemodiafiltration

    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.

05

What researchers measure

Primary outcomes

  1. Clearance of moderate molecule substance

    Clearance rate of b2-microglobulin for one dialysis.

    Time frame: 4 hours after dialysis

Secondary outcomes

  1. 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.

    Time frame: 4 hours after dialysis

06

Study locations

1 of 1 sites recruiting
  • Guangdong General Hospital
    Guangzhou, Guangdong 510080, China
    • wei shi, MD,PhD · Contact · 13925056339@163.com · +86-20-83850849
    • Yi Li, Master · Contact · 13580588265@139.com · +86-20-81346722
    • 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 · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03456232
Lead sponsor
Guangdong Provincial People's Hospital
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Dec 21, 2017
Primary completion
Mar 10, 2018 (estimated)
Completion
Mar 20, 2018 (estimated)
Last update
Mar 7, 2018

Study contacts

Yi Li, Master
Contact
13580588265@139.com
+86-20-81346722
Wei Shi, MD,PhD
principal investigator · Guangdong Provincial People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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