Coronary Artery Bypass
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERStandard Glucommander Protocol (SGP)
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.
OTHEROptimized Glucommander (OGM)
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.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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: 1. Standard Glucommander Protocol (SGP) 2. Optimized Glucommander (OGM)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients admitted for CABG and/or open heart valve surgery 2. Must have a 0.05 initial multiplier setting for the Glucommander based on the manufacturers recommendations 3. Age of 40-75, inclusive
Exclusion criteria
1. History of severe hypoglycemia within six months of hospital admission 2. Currently undergoing dialysis or renal replacement therapy 3. Women of childbearing potential 4. Patients with endocarditis needing valve replacement 5. Participation in another clinical trial at the time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exposure to risk of hypoglycemia | 24 hours of post-operative hospital stay | Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exposure to risk of hypoglycemia | 48 hours of post-operative hospital stay | Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI). |
Countries
United States
Contacts
Primary ContactAnna Buhle
Backup Contactleon farhi, PhD
Outcome results
None listed