Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

Study Overview
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Brief Summary
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The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.

Detailed Description
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Patients undergoing heart surgery at the Heart Institute (InCor) will be randomized and in accordance with a list of random numbers, generated by a computer program, are allocated in one of the treatment groups (conventional or intensive) when the blood glucose value recorded is greater than 200 mg/dl on two consecutive measures in an interval of 30 minutes.Conventional Group (GCon): patients randomized to the conventional group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl. Group intensive (GInt): patients randomized to the intensive group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 90 mg/dl and 110 mg/dl. The insulin dose adjustment will be based on measurements of arterial blood glucose undiluted, held at intervals of one to 4 hours with the use of a monitoring system of glucose and beta-blood ketone (Freestyle Precision Pro, Abbott). The dosage is adjusted according to an algorithm by a team of intensive care nurses, trained for this purpose and assisted by a study physician not involved in the clinical care of patients. On admission, all patients will receive intravenous glucose solution continuously (200 to 300 g in 24 hours). As soon as possible, the patient will be nurtured according to the routine of Surgical ICU for nutrition in the postoperative period of cardiac surgery patient.

Official Title
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Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

Conditions
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Hyperglycemia

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing heart surgery; Age greater than 18 years; Sign the informed consent form; Capillary blood glucose greater than 200mg/dL ICU admission Exclusion Criteria: Admitted for surgical repair of congenital heart defects; Dialytic Chronic renal failure; Participation in other research protocol; Diagnosis of HIV/AIDS; Pregnant.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Group<br>Patients randomized for Conventional Group will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl. | Drug: Insulin<br>* All patients will receive insulin. However, the infusion flow will be different according to the group.<br>* Other names: Glycemic Control;|
| Experimental: Moderate Group<br>Patients randomized for ModerateGroup will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 100 mg/dl and 130 mg/dl. | Drug: Insulin<br>* All patients will receive insulin. However, the infusion flow will be different according to the group.<br>* Other names: Glycemic Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection of surgical wound infection | The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for reoperation | This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines | 30 days | 
| Acute renal injury (defined by the KDIGO classification) | This outcome measure will be assessed according to the KDIGO Criterion | 30 days | 
| Infection of the bloodstream |  | 90 days | 
| Prolonged mechanical ventilation |  | 90 days | 
| Need for transfusion of blood products |  | 90 days | 
| Occurrences of hypoglycemia |  | 90 days |