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A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181544
First Posted: August 13, 2010
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Louisville
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
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.

Condition Intervention
Renal Failure Chronic Requiring Hemodialysis Procedure: Heparin dose titration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 5
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heparin dose titration 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181544


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202-1718
Sponsors and Collaborators
Baxter Healthcare Corporation
University of Louisville
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Richard A. Ward, Ph.D. University of Louisville
  More Information

Publications:
Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951.
Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003.

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01181544     History of Changes
Other Study ID Numbers: Gambro PI 2012
First Submitted: August 11, 2010
First Posted: August 13, 2010
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by Baxter Healthcare Corporation:
Anticoagulation
Heparin
Hemodialysis
Dialysis
Renal Dialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action