Clinical trial NCT01092455: Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Dialysis
Keywords: End Stage Renal Disease
Renal Dialysis
Hemodialysis therapy
Heparin
Citrasate
Anticoagulant
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the hemodialysis population in the participating facilities (study sites).

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline.
timeFrame: Baseline and 6 months
measure: Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline.
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Avantus Renal Therapy-Saint Raphael Dialysis Center
state: Connecticut
city: New York
country: United States
facility: Irving Place Dialysis Center
state: New York
city: New York
country: United States
facility: Upper Manhattan Dialysis Clinic
state: New York
city: New York
country: United States
facility: Yorkville Dialysis Center
state: New York
city: Houston
country: United States
facility: DaVita Medical Center Houston
state: Texas
city: San Antonio,
country: United States
facility: DaVita Northwest Medical Center
state: Texas
city: San Antonio
country: United States
facility: DaVita Rivercenter Dialysis Clinic
state: Texas
city: San Antonio
country: United States
facility: DaVita Downtown Dialysis Clinic
state: Texas
Study officials:
affiliation: Fresenius Medical Care North America
name: Jeffrey J Sands, MD MMM
role: STUDY_DIRECTOR
References: