The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

Chronic Kidney Disease Clinical Trial

Official title:

The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466959
• Other study ID #: ID24009
• Status: Completed
• Phase: N/A
• First received: October 11, 2011
• Last updated: March 23, 2013
• Start date: November 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD		2 weeks after CD exposure, 2 weeks after AD exposure	No
Secondary	The change from baseline in the number of bleeding events, and bleeding time after HD.		After 2 weeks of exposure to CD	Yes
Secondary	The change from baseline in the number of intradialytic hypotension episodes and the change from baseline in the QT interval		2 weeks after intervention exposure	No
Secondary	The change in small and middle solute clearance from baseline.		2 weeks post exposure	No
Secondary	The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3).		2 weeks post exposure	No
Secondary	The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.		2 weeks	No