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A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

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ClinicalTrials.gov Identifier: NCT01181544
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
University of Louisville
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Tracking Information
First Submitted Date  ICMJE August 11, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date May 8, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm [ Time Frame: up to 8 weeks ]
The objective is to titrate each patient's heparin dose to the level that achieves adequate anticoagulation for that patient as assessed by the change in blood compartment volume of the dialyzer from pre- to post-dialysis. The strategy that will be used is the Robbins-Monro stochastic approximation algorithm.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers [ Time Frame: up to 8 weeks ]
Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis
Official Title  ICMJE Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
Brief Summary During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Failure Chronic Requiring Hemodialysis
Intervention  ICMJE Procedure: Heparin dose titration
Patients will begin the study using their currently prescribed heparin doses - both bolus and constant infusion - for three treatments to establish a baseline and provide information on inter-treatment variability in dialyzer clotting. Subsequently, the bolus and infusion rates will be titrated either upward or downward based on the Robbins-Monro process and an evaluation of dialyzer clotting during the preceding treatment. Heparin doses will be adjusted for a total of 30 dialyses.
Study Arms  ICMJE Experimental: Heparin dose titration
Intervention: Procedure: Heparin dose titration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2010)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults 18 years of age or older
  • Stable hemodialysis prescription prior to study enrollment
  • Dialyzing through a native fistula or Gore-Tex graft
  • Blood access must be able to provide a blood flow rate of 400 ml/min

Exclusion Criteria:

  • Non-compliance with dialysis
  • Hematocrit less than 28%
  • Active Infection
  • Diagnosis of Heparin-Induced Thrombocytopenia (HIT)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01181544
Other Study ID Numbers  ICMJE Gambro PI 2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE
  • University of Louisville
  • Gambro Renal Products, Inc.
Investigators  ICMJE
Principal Investigator: Richard A. Ward, Ph.D. University of Louisville
PRS Account Baxter Healthcare Corporation
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP