Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

Not Applicable

Completed

Interventions: Other: insulin at the standard of care levels
Other: Hyperinsulinemic-normoglycemic clamp

Brief Summary: 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.

Detailed Description: 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 outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery.

Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.

Recruitment & Eligibility

Inclusion Criteria

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)
kidney disease requiring renal replacement therapy

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Any Major Morbidity/30-day Mortality	within 30 days post surgery	a composite (any versus none) of the following major postoperative complications occurring: 1. all-cause postoperative mortality 2. failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation 3. serious postoperative infection 4. acute postoperative kidney injury requiring renal replacement therapy; 5. new postoperative focal or global neurologic deficit.

Secondary Outcome Measures

Name	Time	Method
Post Operative Atrial Fibrillation	15 - 30 days post operative	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
Duration of Intensive Care Stay	ICU stay hours during hospital stay after surgery, on average of 25 hours	Hours from date of surgery to discharge from intensive care unit
a Composite of Minor Postoperative Complications	within 30 days after surgery	a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days.
Duration of Hospitalization	starting post operative day one to discharge from hospital, on an average of 8 days	Days from date of surgery to hospital discharge
All-cause Mortality	one year post operative	All-cause mortality identified during one-year follow-up.