Chronic Kidney DiseaseNCT01466959
The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
A study testing citrate dialysate (CD) and acetic-acid based dialysate (AD) in people with Chronic Kidney Disease, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- citrate dialysate (CD) and acetic-acid based dialysate (AD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic stable HD patients ≥ 18 years
- on HD at least three times per week for at least 3 months
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- citrate dialysate (CD), acetic-acid based dialysate (AD)
- Keywords
- hemodialysis, dialysate, acetate based dialysate, citrasate dialysate, heparin anticoagulation, hemodynamic stability
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citrate dialysate (CD)Other
Also called Citrasate, Citric acid dialysate
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)Other
Also called Acetic acid dialysate, Acetate dialysate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: acetic-acid based dialysate (AD) |
| CD - citrasate dialysate | Experimental | Dialysis with a citric acid based dialyasate. Receives: Other: citrate dialysate (CD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD
Measured: 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.
Measured: 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
Measured: 2 weeks after intervention exposure
The change in small and middle solute clearance from baseline.
Measured: 2 weeks post exposure
The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3).
Measured: 2 weeks post exposure
The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jennifer MacRae, University of Calgary
- Investigators
- Jennifer M MacRae, MD FRCPC, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466959
- Sponsor's protocol ID
- ID24009
- Status last verified
- Mar 2013
- First submitted
- 11 Oct 2011
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38189593Tai 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.
PubMed 26303208
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT01466959
- Acronym / sponsor ID
- ID24009
- Conditions
- Chronic Kidney Disease
- Keywords
- hemodialysis, dialysate, acetate based dialysate, citrasate dialysate, heparin anticoagulation, hemodynamic stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD- acetic acid dialysate | Active comparator | Other: acetic-acid based dialysate (AD)AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis. |
| CD - citrasate dialysate | Experimental | Other: citrate dialysate (CD)Dialysis with a citric acid based dialyasate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic stable HD patients ≥ 18 years
- on HD at least three times per week for at least 3 months
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citrate dialysate (CD)Also: Citrasate, Citric acid dialysateCitrasate (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 | CD - citrasate dialysate |
| acetic-acid based dialysate (AD)Also: Acetic acid dialysate, Acetate dialysateAcetate 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 | AD- acetic acid dialysate |
Primary outcome
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
5 secondary outcomes
The change from baseline in the number of bleeding events, and bleeding time after HD.
Time frame: 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
Time frame: 2 weeks after intervention exposure
The change in small and middle solute clearance from baseline.
Time frame: 2 weeks post exposure
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
The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
- Derived from this study: PubMed 38189593Natale 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.
- Derived from this study: PubMed 26303208Tai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M MacRae, MD FRCPC study director
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citrate dialysate (CD) and acetic-acid based dialysate (AD) in people with Chronic Kidney Disease, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01466959, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.