Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

• health-related quality of life [ Time Frame: 15 and 30 days post operative ] [ Designated as safety issue: No ]
  To compare the randomized groups on continuous outcomes including health-related quality of life (at 15 and 30) days
• post operative atrial fibrillation [ Time Frame: 15-30 days post operative ] [ Designated as safety issue: No ]
  Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery
• post operative delirium [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
  New postoperative delirium as determined by a Delirium Battery consisting of the Richmond Agitation and Sedation Scale (RASS), Confusion Assessment Method for the ICU (CAM-ICU), Mini Mental State Examination (MMSE - leaving out the drawing), Memorial Delirium Assessment Scaler, Modified Delirium Symptom Interview, and abbreviated Digit Span. Patients will be assessed twice a day for a maximum of five days postoperatively.
• wound healing [ Time Frame: 15-30 days post operative ] [ Designated as safety issue: No ]
  Measured by wound collagen disposition, hydroxyproline content, and other mediators of wound healing (e.g. collagenase, cell matrix components, and matricellular proteins such as thrombospondin).
• Duration of hospitalization [ Time Frame: starting post operative day one ] [ Designated as safety issue: No ]
  Days from day of surgery to hospital discharge.
• Duration of Intensive Care stay [ Time Frame: starting post operative day one ] [ Designated as safety issue: No ]
  Days from day of surgery to discharge from intensive care unit.
• all-cause mortality [ Time Frame: one year post operative ] [ Designated as safety issue: No ]
  All-cause mortality identified during one-year follow-up.

Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.

• Other: Hyperinsulinemic-normoglycemic clamp
  Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
  Other Names:

  • clamp
  • Hyperinsulinemic
• Other: insulin at the standard of care levels
  Subjects will be administered insulin at the standard of care levels established by the participating institution.
  Other Name: insulin

• Experimental: Hyperinsulinemic-normoglycemic clamp
  Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
  Intervention: Other: Hyperinsulinemic-normoglycemic clamp
• Insulin at the standard of care levels
  Group B will be administered insulin at the standard of care levels established by the participating institution.
  Intervention: Other: insulin at the standard of care levels

Inclusion Criteria:

• Age 18-90 years old
• Scheduled for cardiac surgery requiring cardiopulmonary bypass

Exclusion Criteria:

• Off-pump surgical procedures
• Anticipated deep hypothermic circulatory arrest
• In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL) levels (at RVH or CC, respectively)
• Any contraindications to the proposed interventions
• Active infection, including patients with endocarditis or infected pacemaker leads.
• Any infection requiring long- term antibiotics ( > 14 days)