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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randolph Quinn, Fresenius Medical Care North America
ClinicalTrials.gov Identifier:
NCT01092455
First received: March 11, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Renal Dialysis
Drug: Heparin N reduction
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care North America:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-inferiority of conductivity clearance when dialyzed with Citrasate and 66.7% baseline Heparin dose as compared to baseline. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Dialyzer or system clotting with Citrasate plus reduced Heparin compared to baseline. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned 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.
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.
Other Names:
  • Citrasate®
  • Heparin N

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from the hemodialysis population in the participating facilities (study sites).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092455

Locations
United States, Connecticut
Avantus Renal Therapy-Saint Raphael Dialysis Center
New Haven, Connecticut, United States, 06511
United States, New York
Irving Place Dialysis Center
New York, New York, United States, 10003
Yorkville Dialysis Center
New York, New York, United States, 10028
Upper Manhattan Dialysis Clinic
New York, New York, United States, 10025
United States, Texas
DaVita Medical Center Houston
Houston, Texas, United States, 77004
DaVita Downtown Dialysis Clinic
San Antonio, Texas, United States, 78215
DaVita Rivercenter Dialysis Clinic
San Antonio, Texas, United States, 78212
DaVita Northwest Medical Center
San Antonio,, Texas, United States, 78229
Sponsors and Collaborators
Randolph Quinn
Investigators
Study Director: Jeffrey J Sands, MD MMM Fresenius Medical Care North America
  More Information

No publications provided

Responsible Party: Randolph Quinn, Manager, Regulatory Affairs, Fresenius Medical Care North America
ClinicalTrials.gov Identifier: NCT01092455     History of Changes
Other Study ID Numbers: 208-09
Study First Received: March 11, 2010
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fresenius Medical Care North America:
End Stage Renal Disease
Renal Dialysis
Hemodialysis therapy
Heparin
Citrasate
Anticoagulant

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014