Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
Condition: Diabetes
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Several prospective cohort studies as well as randomized clinical trials (RCT) in cardiac
      surgery patients have shown that intensified insulin therapy (target BG: 110-140 mg/dl)
      results in a reduction in short- and long-term mortality compared with conventionally treated
      patients. The results of recent international trials in critically ill patients; however,
      have failed to show a significant improvement in mortality or have even shown increased
      mortality risk as well as increased number of hypoglycemic events with intensive compared to
      less intensive glycemic control. Based on the results of these ICU trials, new ADA and AACE
      guidelines recommended a glycemic target between 140 and 180 mg/dl in the ICU including
      cardiac surgery patients. There is concern that such high BG targets might increase the risk
      of hospital complications in cardiac surgical patients in whom intensive glucose control has
      consistently reduced infections, length of hospital stay, resource utilization, and
      cardiac-related mortality. The overall objective of this proposal is to conduct the first
      prospective RCT to determine the optimal BG target during the perioperative period in
      hyperglycemic subjects who undergo CABG in the United States. Subjects will be randomized to
      undergo intensive insulin therapy adjusted to maintain a BG between 100 mg/dl and 140 mg/dl
      or to a conventional glucose control with a target BG between 141 mg/dl and 200 mg/dl in the
      ICU. The central hypothesis of this proposal is that intensive insulin management will reduce
      perioperative complications compared to a conventional BG control in cardiac surgery
      patients.
    

Intervention name(s): Regular insulin (intensive treatment); Regular Insulin (conventional treatment)
Intervention type(s): Other; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Coronary Artery Bypass Surgery; Glycemic control; Insulin infusion