Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment

Renal Dialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092455
• Other study ID #: 208-09
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2010
• Last updated: August 31, 2011
• Start date: December 2009
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

Drug:
• Heparin N reduction
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.

Locations

Country	Name	City	State
United States	DaVita Medical Center Houston	Houston	Texas
United States	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	New York	New York
United States	DaVita Downtown Dialysis Clinic	San Antonio	Texas
United States	DaVita Rivercenter Dialysis Clinic	San Antonio	Texas
United States	DaVita Northwest Medical Center	San Antonio,	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Randolph Quinn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Baseline and 6 months	No
Secondary	Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline.		Baseline and 6 months	No
Secondary	Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline.		baseline and 6 months	Yes