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The purpose of this study is to determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis.
During hemodialysis, waste products are removed from the blood by diffusion across the dialyzer membrane into an electrolyte solution known as dialysate. Dialysate is produced from acid concentrate, bicarbonate solution and water using a three stream proportioning system that mixes the acid concentrate, bicarbonate and water to produce the final dialysate. Patients are typically anticoagulated with heparin during dialysis to prevent blood from clotting in the extracorpoeial circuit. Heparin use is associated with significant risks including the possibility of bleeding, heparin induced thrombocytopenia (HIT) and contamination. For these reasons, the possibility of reducing heparin dose while maintaining HD adequacy is clinically attractive. Citrasate® is an FDA approved acid concentrate that contains citric acid (citrate) rather than acetic acid (acetate) which is traditionally used in acid concentrate. Citrate in higher concentrations is also a known anticoagulant. We are therefore conducting this study to determine whether the use of Citrasate, citric acid dialysate enables the reduction of the heparin requirements in patients undergoing hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrasate and heparin reduction | Sequential hemodialysis treatment study in which all enrollees move through four (4) separate treatment phases. Results from the separate phases will be compared to standard bicarbonate dialysis with standard does of heparin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin N reduction | Drug | Dialysis with Citrasate, acid concentrate plus 100% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 80% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 66.7% of patient's standard heparin N dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of dialyzer conductivity clearance (KECN) when dialyzed with Citrasate, acid concentrate and 80% of baseline Heparin dose compared to dialysis using standard bicarbonate dialysate and standard dose heparin N (baseline). | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline. | Baseline and 6 months | |
| Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline. | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from the hemodialysis population in the participating facilities (study sites).
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J Sands, MD MMM | Fresenius Medical Care North America | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avantus Renal Therapy-Saint Raphael Dialysis Center | New Haven | Connecticut | 06511 | United States | ||
| Irving Place Dialysis Center |
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|
|
| New York |
| New York |
| 10003 |
| United States |
| Upper Manhattan Dialysis Clinic | New York | New York | 10025 | United States |
| Yorkville Dialysis Center | New York | New York | 10028 | United States |
| DaVita Medical Center Houston | Houston | Texas | 77004 | United States |
| DaVita Rivercenter Dialysis Clinic | San Antonio | Texas | 78212 | United States |
| DaVita Downtown Dialysis Clinic | San Antonio | Texas | 78215 | United States |
| DaVita Northwest Medical Center | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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