Citrasate® Effect On Heparin N Requirements During Hemodialysis Treatment: A Phase IV,Study to Investigate the Effects of Citrasate on Heparin N Requirements During Hemodialysis Treatment in Subjects Maintained on Thrice Weekly Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 8
- Primary Endpoint
- 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).
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is capable of giving informed consent, or has an acceptable surrogate capable of giving consent on the subject's behalf.
- •ESRD maintained on thrice weekly HD
- •Stable Heparin prescription (Heparin dose) for the previous 4 weeks
- •Dialyzed using bolus heparin anticoagulation with dose >/= 2000 units per treatment
- •Hgb >/= 9.5 prior to study start
- •eKt/V >/= 1.0 (or spKt/V >/= 1.2) in the monthly lab work prior to study start
Exclusion Criteria
- •Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- •Patient is maintained on Coumadin therapy or LMW heparin
- •Known history of HIT, coagulopathy or any other bleeding and/or thrombotic disorders
- •Patients dialyzed with < 2000 units of Heparin per treatment
- •Dialyzed without heparin
- •Known pregnancy
- •Dialyzed with reuse of hemodialyzers
- •Documented clotted dialyzer or dialysis lines in last 30 days (1 month) requiring changing dialyzer, bloodlines or terminating treatment
- •Randomized in a clinical trial involving anticoagulation in the last 30 days
Arms & Interventions
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.
Intervention: Heparin N reduction (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Randolph Quinn
Manager, Regulatory Affairs
Fresenius Medical Care North America