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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| CD - citrasate dialysate | Experimental | Dialysis with a citric acid based dialyasate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M MacRae, MD FRCPC | University of Calgary | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38189593 | Derived | 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. | |
| 26303208 | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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. |
|
|
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |