Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
Condition: Diabetes
Intervention: Regular insulin (intensive treatment); Regular Insulin (conventional treatment)
Intervention description: Titration of the IV insulin rate for glucose goal 100-140 mg/dL; Titration of the IV insulin rate for glucose goal 141-180 mg/dl
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes; Coronary Artery Bypass Surgery; Glycemic control; Insulin infusion

Summary:

      High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are
      associated with increased risk of hospital complications. Blood sugar control with
      intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac
      bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before
      or after surgery). It is not clear what the best insulin regimen is or what is the best blood
      sugar target in these patients. Accordingly, this research study aims to determine optimal
      blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will
      be divided in two groups. The intensive insulin group will be maintained at blood glucose
      between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180
      mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are
      approved for use in the treatment of patients with diabetes by the FDA (Food and Drug
      Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery
      will be recruited in this study. Patients will be recruited at Emory University Hospital,
      Emory Midtown Hospital and Grady Memorial Hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females between the ages of 18 and 80 years undergoing CABG +/- valve
             surgery.

          2. Post surgical hyperglycemia (BG > 140 mg/dl).

          3. Patients with and without a history of type 2 diabetes

        Exclusion Criteria:

          1. Patients requiring combination CABG with additional procedures such aorta replacement.

          2. Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR <
             30 ml/min) or clinically significant hepatic failure.

          3. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and
             hyperosmolar hyperglycemic state.

          4. Moribund patients and those at imminent risk of death (brain death or cardiac
             standstill).

          5. Patients or next-to-kin with mental condition rendering the subject or family member
             unable to understand the nature, scope, and possible consequences of the study.

          6. Female subjects who are pregnant or breast-feeding at time of enrollment into the
             study.