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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

Page last updated: August 23, 2015

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