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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21EB018052 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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The primary objective of this study is to assess the performance of an in silico designed alternative protocol for control of stress hyperglycemia of inpatients treated for Coronary Artery Bypass Graft (CABG) or valve replacement surgery in the University of Virginia cardiothoracic ICU.
The hypothesis of the study is that settings for the Glucommander protocol can be optimized in silico to achieve statistically improved low blood glucose index (LBGI) within the subpopulation of CABG and valve replacement patients who both receive Glucommander-based insulin therapy and meet Manufacturer's guidelines for starting with an initial multiplier value of .052, without risking clinically significant increase in exposure to hyperglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Glucommander Protocol (SGP) | Active Comparator | CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations |
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| Optimized Glucommander (OGM) | Experimental | CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Glucommander Protocol (SGP) | Other | Subjects receive standard Glucommander-based insulin therapy from the clinical staff of U.Va.'s cardiothoracic ICU and follow manufacturer's guidelines for starting with an initial multiplier value of .05. |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to risk of hypoglycemia | Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI). | 24 hours of post-operative hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to risk of hypoglycemia | Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI). | 48 hours of post-operative hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Buhle | Contact | 4349898257 | ab7ga@virginia.edu | |
| leon farhi, PhD | Contact | 4342966583 | leon@virginia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vrginia | Recruiting | Charlottesville | Virginia | 22901 | United States |
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Subjects with CABG or open heart valve surgery will be enrolled in the study. They will be randomized to receive one of the following treatments:
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| Optimized Glucommander (OGM) | Other | The experimental arm of the study involves treating subjects with a lower initial multiplier (.02 versus .05), a higher set of BG thresholds (140-180 mg/dl vs 120-160) in the first eight (8) hours of care for avoidance of hypoglycemia in that time period, and a requirement for consistent hourly-or-faster sampling of BG (as opposed to the Glucommander recommendation which is dependent on the trajectory of BG and can sometimes allow intervals of two hours between samples). After the eight (8) hours, the Glucommander is set back to the standard protocol for the entire duration of the subject's post-operative hospital stay. |
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