Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Other: Hyperinsulinemic-normoglycemic clamp
* Other: insulin at the standard of care levels


Participation Criteria
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Eligibility Criteria
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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) kidney disease requiring renal replacement therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperinsulinemic-normoglycemic clamp<br>Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. | Other: Hyperinsulinemic-normoglycemic clamp<br>* Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.<br>* Other names: Hyperinsulinemic;|
| Other: Insulin at the standard of care levels<br>Group B will be administered insulin at the standard of care levels established by the participating institution. | Other: insulin at the standard of care levels<br>* Subjects will be administered insulin at the standard of care levels established by the participating institution.<br>* Other names: insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Major Morbidity/30-day Mortality | a composite (any versus none) of the following major postoperative complications occurring: all-cause postoperative mortality 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 serious postoperative infection acute postoperative kidney injury requiring renal replacement therapy; new postoperative focal or global neurologic deficit. | within 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Atrial Fibrillation | 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 | 15 - 30 days post operative | 
| Duration of Hospitalization | Days from date of surgery to hospital discharge | starting post operative day one to discharge from hospital, on an average of 8 days | 
| Duration of Intensive Care Stay | Hours from date of surgery to discharge from intensive care unit | ICU stay hours during hospital stay after surgery, on average of 25 hours | 
| All-cause Mortality | All-cause mortality identified during one-year follow-up. | one year post operative | 
| a Composite of Minor Postoperative Complications | 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. | within 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperinsulinemic glucose control, cardiac surgery, Outcome