The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

NCT01466959 | Completed DMC

• 1 other identifier: ID24009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

hemodialysis; dialysate; acetate based dialysate; citrasate dialysate; heparin anticoagulation; hemodynamic stability

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

  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

  2 weeks after intervention exposure

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

  2 weeks post exposure

• The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3).

  2 weeks post exposure

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

  2 weeks

Study Arms (2)

AD- acetic acid dialysate

ACTIVE COMPARATOR

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)

CD - citrasate dialysate

EXPERIMENTAL

Dialysis with a citric acid based dialyasate.

Other: citrate dialysate (CD)

Interventions

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.

Also known as: Citrasate, Citric acid dialysate

CD - citrasate 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.

Also known as: Acetic acid dialysate, Acetate dialysate

AD- acetic acid dialysate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic stable HD patients ≥ 18 years
• on HD at least three times per week for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (2)

• 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.

  PMID: 38189593 DERIVED

• 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.

  PMID: 26303208 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer M MacRae, MD FRCPC

  University of Calgary

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

CA (1)