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A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heparin dose titration
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure Chronic Requiring Hemodialysis focused on measuring Anticoagulation, Heparin, Hemodialysis, Dialysis, Renal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heparin dose titration

Arm Description

Outcomes

Primary Outcome Measures

Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm
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
Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.

Full Information

First Posted
August 11, 2010
Last Updated
May 5, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
University of Louisville, Gambro Renal Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01181544
Brief Title
A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis
Official Title
Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
University of Louisville, Gambro Renal Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Requiring Hemodialysis
Keywords
Anticoagulation, Heparin, Hemodialysis, Dialysis, Renal Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heparin dose titration
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Heparin dose titration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm
Description
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.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers
Description
Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A. Ward, Ph.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1718
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
681809
Citation
Farrell PC, Ward RA, Schindhelm K, Gotch F. Precise anticoagulation for routine hemodialysis. J Lab Clin Med. 1978 Aug;92(2):164-76.
Results Reference
background
PubMed Identifier
9754457
Citation
Smith BP, Ward RA, Brier ME. Prediction of anticoagulation during hemodialysis by population kinetics and an artificial neural network. Artif Organs. 1998 Sep;22(9):731-9. doi: 10.1046/j.1525-1594.1998.06101.x.
Results Reference
background
Citation
Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951.
Results Reference
background
Citation
Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003.
Results Reference
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A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

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