The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

NCT ID: NCT01466959

Last Updated: 2013-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

acetic-acid based dialysate (AD)

Intervention Type OTHER

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.

CD - citrasate dialysate

Dialysis with a citric acid based dialyasate.

Group Type EXPERIMENTAL

citrate dialysate (CD)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Citrasate Citric acid dialysate Acetic acid dialysate Acetate dialysate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr Jennifer MacRae

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer M MacRae, MD FRCPC

Role: STUDY_DIRECTOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

Reference Type DERIVED
PMID: 38189593 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26303208 (View on PubMed)

Other Identifiers

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ID24009

Identifier Type: -

Identifier Source: org_study_id

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