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NCT Number: NCT01466959

The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

citrate dialysate (CD)

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.

Other names: Citrasate, Citric acid dialysate

acetic-acid based dialysate (AD)

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.

Other names: Acetic acid dialysate, Acetate dialysate

Primary outcomes

  1. 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 outcomes

  1. The change from baseline in the number of bleeding events, and bleeding time after HD.

    Time frame: After 2 weeks of exposure to CD

  2. 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

  3. The change in small and middle solute clearance from baseline.

    Time frame: 2 weeks post exposure

  4. 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

  5. The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2011
Registry last updated
Mar 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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