Strict or Liberal Insulin Protocol Following Coronary Artery Bypass Graft (CABG) Surgery
Strict or Liberal Insulin Protocol Following Coronary Artery Bypass Graft (CABG) Surgery
This research study is designed to better understand post-operative complications as related
 to the tightness of blood sugar control. It is also hoped that we may learn that a more
 liberal control of your blood sugars is not inferior to the current strict glucose control.
 Our ultimate goal is to evaluate if there is any change in the rates of complications between
 the two groups. We will be comparing the current strict blood glucose control with a more
 liberal target for blood sugars.
Hyperglycemia is commonly encountered following cardiac surgery, whether a patient has a
 history of diabetes or not. Hyperglycemia has been associated with increased perioperative
 morbidity and mortality; several studies have demonstrated that glycemic control utilizing
 insulin protocols improves operative mortality, lowers operative morbidity (mediastinitis,
 atrial fibrillation), and improves long-term survival. However, the optimal target for serum
 glucose has not been established in post-CABG patients.

 Methods:

 All CABG patients will be consented prior to surgery. Inclusion criteria for non-diabetic
 patient is a random fingerstick blood glucose (FSBG) above >150 mg/dL prior, during, or
 immediately following surgery. All patients with history of diabetes mellitus (Type 1 or Type
 II) will be immediately eligible for inclusion.

 Following CABG surgery, if the patient was started intra-operatively on an insulin infusion,
 then that patient will be randomized to one of two treatment target groups: Group 1 [Blood
 Glucose (BG): 80 mg/dL-120 mg/dL] or Group 2 [BG: 121-180 mg/dL]. The randomization design
 will be a 1:1 allocation of patients between the two groups, with both diabetic and
 non-diabetic patients enrolled in both arms of the study. Patients will be maintained on an
 electronic-based protocol of intravenous insulin for a minimum of 72 hrs postoperatively.
 Patients remaining in the CVICU greater than 72 hrs will have their intravenous insulin
 continued until transfer to the step-down unit.

 The Glucommander© will be programmed to adjust the insulin drip to one of these two target
 groups. The nursing staff will not be blinded to treatment group allocation. The primary
 endpoint with be a composite of operative death, major adverse cardiac events (MACE: death,
 myocardial infarction, re-vascularization), STS Defined Major Morbidity (re-operation,
 Cerebrovascular accident, Deep Sternal Wound Infection/Mediastinitis, Prolonged Ventilatory
 Support (> 24 hrs), Acute Renal Failure), and prolonged inotropic support. The pre-specified
 sub-group analysis will compare perioperative outcome of patients with diabetes vs
 non-diabetic patients.

 Hypothesis:

 Our hypothesis is that the perioperative outcome of Group 2 [BG: 121 - 180 mg/dL] will not be
 inferior to Group 1 [BG: 80-120 mg/dL]. We anticipate significantly more hypoglycemic events
 in Group 1.
Inclusion Criteria:

 1. All diabetic patients going for isolated, non-emergent CABG surgery at Inova Fairfax
 Hospital (IFH).

 2. Non diabetic patients going for isolated, non-emergent CABG Surgery at IFH that are
 found to have a finger stick blood glucose > 150 mg/dl, either pre-operative, during
 the procedure or post-operatively.

 3. Those patients that meet Inclusion Criteria #1 OR #2 AND have been started on an
 insulin infusion while in the operative room will be enrolled.

 Exclusion Criteria:

 1. Patients that are not undergoing CABG surgery.

 2. Patients that post-CABG surgery are not on an insulin infusion.

 3. Patients that are undergoing other procedures in addition to CABG will be excluded.
 (ie. CABG + valve repair)