Benefits of GIK in Cardiac Surgery Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of modified glucose - insulin - potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).

Detailed Description
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Cardiopulmonary bypass (CPB) is a necessary technique to maintain the circulation during cardiac surgery. But CPB itself is associated with a series of problems of organs, such as hyperglycemia induced by neuroendocrine stress. The research showed that hyperglycemia induced by stress would cause a worsened hospital outcome for patients undergoing cardiac surgery. Intraoperative and postoperative glucose control is beneficial for patients. It has been for more than 40 year since the first application of glucose - insulin - potassium (GIK) in cardiac surgery but the clinical application of GIK shows controversial results. The beginning time of application and the ratio of glucose and insulin may be the key reasons for the controversy. In our pilot trial of 40 valve replacement cases, we found that perioperative treatment of GIK with an insulin-glucose ratio of 1:3 showed beneficial effects during heart surgery. Therefore, the investigators are planning to continue to test this modified GIK regimen for more heart surgery patients and determine whether GIK may have cardioprotective effects on patients undergoing CPB surgery. Myocardial biopsies for biological mechanism analysis will be performed prior to CPB, 15 min after aortic cross clamp application and 15 min after reperfusion only in a small cohort. Myocardial biopsies will be snap frozen or fixed.

Official Title
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Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Conditions
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Cardiac Surgery, Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: GIK
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 70 years of age Elective cardiac surgery with first time cardiopulmonary bypass Left ventricular ejection fraction(LVEF) ≥ 30% Informed agreement signed Exclusion Criteria: Previous cardiac surgery Emergent surgery Cardiac surgery without the use of cardiopulmonary bypass Diabetes mellitus Severe renal insufficiency Severe respiratory insufficiency Serious preoperative illness (sepsis, active infection or active malignancy requiring treatment) Pregnant woman or positive pregnancy test History of drug abuse Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion Enrollment in another clinical study Lack of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GIK<br>glucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl). | Drug: GIK<br>* Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.<br>* Other names: Glucose-insulin-potassium;|
| Placebo Comparator: Control<br>6.12 g/L sodium acetate, 5.85 g/L sodium chloride, 0.3 g/L potassium chloride and 0.33 g/L calcium chloride | Drug: Control<br>* Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.<br>* Other names: Balanced salt solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants of the major adverse cardiac events | The composite of major adverse cardiac events included acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome, congestive heart failure, arrhythmia and all-cause death. | Stay in hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | until the study ends | 
| Length of stay in intensive care unit and hospital | Length of stay in intensive care unit and hospital | Stay in intensive care unit and hospital | 
| Number of patients of postoperative complications | Postoperative complications included prolonged ventilation, the use of inotropes, sepsis/infection, renal complications, stroke and reoperation. | Stay in hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose-insulin-potassium, Cardiac surgery