Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment
Information source: Fresenius Medical Care North America
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Dialysis
Intervention: Heparin N reduction (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Randolph Quinn Official(s) and/or principal investigator(s): Jeffrey J Sands, MD MMM, Study Director, Affiliation: Fresenius Medical Care North America
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.
Clinical Details
Official title: 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
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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).
Secondary outcome: Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline.Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Avantus Renal Therapy-Saint Raphael Dialysis Center, New Haven, Connecticut 06511, United States
Irving Place Dialysis Center, 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 Northwest Medical Center, San Antonio,, Texas 78229, United States
DaVita Downtown Dialysis Clinic, San Antonio, Texas 78215, United States
DaVita Rivercenter Dialysis Clinic, San Antonio, Texas 78212, United States
Additional Information
Starting date: December 2009
Last updated: August 31, 2011
|