The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
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|ClinicalTrials.gov Identifier: NCT01466959|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : March 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Other: citrate dialysate (CD) Other: acetic-acid based dialysate (AD)||Not Applicable|
The investigators will perform a randomized, double-blind, two-period crossover trial in chronic HD patients to compare the effect of citrasate dialysate (CD) and usual acetic-acid based dialysate (AD) on the cumulative intradialytic heparin dose. There is a four week run in phase followed by two weeks of intervention AD or CD followed by the remaining AD or CD intervention.
The primary outcome is change in intradialytic heparin dose achieved with citrasate compared with acetate dialysate. Secondary outcomes are the effect of CD compared with AD on systemic anticoagulation, bleeding time after HD, metabolic parameters, dialysis adequacy, inflammation, hemodynamic stability, and intra-rater and inter-rater reliability of the dialyzer clotting score.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: AD- acetic acid dialysate
AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis.
Other: acetic-acid based dialysate (AD)
Acetate based dialysate; AD is the standard dialysate used in hemodialysis runs 4 hours three times weekly. For the study it will be used for a period of 2 weeks and compared to the CD study time period.
Experimental: CD - citrasate dialysate
Dialysis with a citric acid based dialyasate.
Other: citrate dialysate (CD)
Citrasate (CD) is substituted as the dialysate during the patients regular dialysis run 4hours three times weekly for a period of 2 weeks. The only difference between citrasate and the regular dialysate is the lack of acetic acid.
- The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD [ Time Frame: 2 weeks after CD exposure, 2 weeks after AD exposure ]
- The change from baseline in the number of bleeding events, and bleeding time after HD. [ Time Frame: After 2 weeks of exposure to CD ]
- The change from baseline in the number of intradialytic hypotension episodes and the change from baseline in the QT interval [ Time Frame: 2 weeks after intervention exposure ]
- The change in small and middle solute clearance from baseline. [ Time Frame: 2 weeks post exposure ]
- The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3). [ Time Frame: 2 weeks post exposure ]
- The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score. [ Time Frame: 2 weeks ]
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): NCT01466959
|University of Calgary|
|Calgary, Alberta, Canada, T2N 2T9|
|Study Director:||Jennifer M MacRae, MD FRCPC||University of Calgary|