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.
Study Type
OBSERVATIONAL
Enrollment
300
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.
Avantus Renal Therapy-Saint Raphael Dialysis Center
New Haven, Connecticut, United States
Irving Place Dialysis Center
New York, New York, United States
Upper Manhattan Dialysis Clinic
New York, New York, United States
Yorkville Dialysis Center
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).
Time frame: Baseline and 6 months
Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline.
Time frame: Baseline and 6 months
Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline.
Time frame: baseline and 6 months
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New York, New York, United States
DaVita Medical Center Houston
Houston, Texas, United States
DaVita Rivercenter Dialysis Clinic
San Antonio, Texas, United States
DaVita Downtown Dialysis Clinic
San Antonio, Texas, United States
DaVita Northwest Medical Center
San Antonio, Texas, United States