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
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure Chronic Requiring Hemodialysis||Procedure: Heparin dose titration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
|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.
- 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.
- 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.
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
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202-1718|
|Principal Investigator:||Richard A. Ward, Ph.D.||University of Louisville|