Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Frequency of Blood Glucose levels (BG) > 140 mg/dl During Post Operative Period |
Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels >140 mg/dl. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. To to determine if dulaglutide can prevent stress-hyperglycemia, the number of BG levels > 140 mg/dl during the post-operative period in patients randomized to dulaglutide or placebo study arms are recorded and compared. |
Up to 7 days postoperatively |
|
Secondary |
Mean blood glucose levels in mg/dL during the Intensive Care Unit (ICU) stay post operatively |
To measure glucose control the mean blood glucose levels in mg/dL during the Intensive Care Unit (ICU) stay post operatively are measured between patients randomized to dulaglutide or placebo arms. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. |
During the ICU stay (Up to 5 days postoperatively) |
|
Secondary |
Number of Participants with Stress-hyperglycemia Requiring Rescue Therapy with Subcutaneous Insulin after Discontinuation of CII |
Patients with two consecutive BG >180 mg/dl, or average daily BG >180 mg/dl will be started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants in need of rescue therapy with subcutaneous insulin post operatively between patients randomized to dulaglutide or placebo arms is recorded and compared. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Number of Participants Needing CII Treatment in the ICU |
Patients with two consecutive BG >180 mg/dl, or average daily BG >180 mg/dl will be started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants needing CII while in the ICU post operatively between patients randomized to dulaglutide or placebo arms is recorded and compared. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Mean blood glucose levels in mg/dL during the hospital stay |
To measure glucose control the mean blood glucose levels in mg/dL during the non-ICU hospital stay post-operatively are measured between patients randomized to dulaglutide or placebo arms. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Mean Units per Hours of Insulin While in the ICU |
The mean insulin dose during the time that participants are in the ICU is assessed as insulin infusions units per hour. |
During the ICU stay (Up to 5 days postoperatively) |
|
Secondary |
Mean Insulin Dose Per Day While in the ICU |
The mean insulin dose during the time that participants are in the ICU is assessed as insulin dose per day. |
During the ICU stay (Up to 5 days postoperatively) |
|
Secondary |
Duration of CII |
The duration of continuous insulin infusion (CII) is assessed in hours. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Days of Subcutaneous (SC) Insulin After Discontinuation of CII |
The number of days that subcutaneous (SC) is required after continuous insulin infusion (CII) is discontinued. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Amount of SC Insulin |
The amount of subcutaneous (SC) insulin required in ICU and non-ICU hospital stay. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Number of Hyperglycemic Events |
The number of hyperglycemic events, defined as BG > 200 mg/dl, during ICU and non-ICU hospital stay. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Number of Hypoglycemic Events |
The number of hypoglycemic events (<70, < 54, and <40 mg/dl) during ICU and non-ICU hospital stay. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Number of Mortality and Complications |
The number of participants experiencing a composite of mortality and complications. Complications include sternal wound infection, bacteremia, pneumonia], acute kidney injury, and acute myocardial infarction. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Number of Gastrointestinal Adverse Events |
The number of gastrointestinal adverse events of nausea, vomiting, ileus, pancreatitis. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
ICU Length of Stay |
The number of days in the ICU. |
During the ICU stay (Up to 5 days postoperatively) |
|
Secondary |
Hospital Length of Stay |
The number of days in the hospital. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Number of ICU Readmissions |
The number of readmissions to the ICU. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Number of Cerebrovascular Events |
The number of cerebrovascular events. |
During the hospital stay (Up to 7 days postoperatively) |
|
Secondary |
Mortality |
The number of participant deaths while in the ICU and hospital. |
During the hospital stay (Up to 7 days postoperatively) |
|