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| Name | Class |
|---|---|
| University of Louisville | OTHER |
| Gambro Renal Products, Inc. | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin dose titration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin dose titration | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A. Ward, Ph.D. | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202-1718 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 681809 | Background | Farrell PC, Ward RA, Schindhelm K, Gotch F. Precise anticoagulation for routine hemodialysis. J Lab Clin Med. 1978 Aug;92(2):164-76. | |
| 9754457 | Background | 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. |
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| Background | Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951. |
| Background | Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003. |