Back to resultsThe Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
citrate dialysate (CD)
acetic-acid based dialysate (AD)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring hemodialysis, dialysate, acetate based dialysate, citrasate dialysate, heparin anticoagulation, hemodynamic stability
Eligibility Criteria
Inclusion Criteria:
- chronic stable HD patients ≥ 18 years
- on HD at least three times per week for at least 3 months
Exclusion Criteria:
- contraindication to heparin
- currently using heparin-free HD
- known clotting disorder
- on warfarin therapy
- dialyzing with a dysfunctional central venous catheter (blood flow rates consistently less than 300mL/min and/or frequent use of thrombolytic)
- history of vascular access dysfunction
- planned vascular access conversion or procedure during the study period
- use of high calcium dialysate
- active medical issue requiring hospitalization
- planned kidney transplant during the study period
- planned conversion of dialysis modality (peritoneal dialysis, nocturnal dialysis) during the study period
- unable to provide informed consent
Sites / Locations
- University of Calgary
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
AD- acetic acid dialysate
CD - citrasate dialysate
Arm Description
AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis.
Dialysis with a citric acid based dialyasate.
Outcomes
Primary Outcome Measures
The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD
Secondary Outcome Measures
The change from baseline in the number of bleeding events, and bleeding time after HD.
The change from baseline in the number of intradialytic hypotension episodes and the change from baseline in the QT interval
The change in small and middle solute clearance from baseline.
The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3).
The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01466959
Brief Title
The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
Official Title
The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An alternative to systemic heparin anticoagulation for HD is citrate dialysate (CD). CD contains a small amount of citric acid rather than acetic acid as the acidifying agent. The use of citrasate may lead to lower heparin requirements in hemodialysis. This is a randomized, double blinded, two-period crossover trial in HD patients to compare the effect of citrasate dialysis (CD) and usual acetic-acid based dialysate (AD) on heparin dose.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
hemodialysis, dialysate, acetate based dialysate, citrasate dialysate, heparin anticoagulation, hemodynamic stability
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD- acetic acid dialysate
Arm Type
Active Comparator
Arm Description
AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis.
Arm Title
CD - citrasate dialysate
Arm Type
Experimental
Arm Description
Dialysis with a citric acid based dialyasate.
Intervention Type
Other
Intervention Name(s)
citrate dialysate (CD)
Other Intervention Name(s)
Citrasate, Citric acid dialysate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
acetic-acid based dialysate (AD)
Other Intervention Name(s)
Acetic acid dialysate, Acetate dialysate
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The change from baseline in the number of bleeding events, and bleeding time after HD.
Time Frame
After 2 weeks of exposure to CD
Title
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
Title
The change in small and middle solute clearance from baseline.
Time Frame
2 weeks post exposure
Title
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
Title
The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic stable HD patients ≥ 18 years
on HD at least three times per week for at least 3 months
Exclusion Criteria:
contraindication to heparin
currently using heparin-free HD
known clotting disorder
on warfarin therapy
dialyzing with a dysfunctional central venous catheter (blood flow rates consistently less than 300mL/min and/or frequent use of thrombolytic)
history of vascular access dysfunction
planned vascular access conversion or procedure during the study period
use of high calcium dialysate
active medical issue requiring hospitalization
planned kidney transplant during the study period
planned conversion of dialysis modality (peritoneal dialysis, nocturnal dialysis) during the study period
unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M MacRae, MD FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Study Director
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26303208
Citation
Tai DJ, Leung K, Ravani P, Quinn RR, Scott-Douglas N, MacRae JM; Alberta Kidney Disease Network. The effect of citrate dialysate on intradialytic heparin dose in haemodialysis patients: study design of a randomised controlled trial. BMC Nephrol. 2015 Aug 25;16:147. doi: 10.1186/s12882-015-0144-z.
Results Reference
derived
Learn more about this trial
The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
We'll reach out to this number within 24 hrs