The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.

Detailed Description
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Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting. We will investigate the impact of short term GIK on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.

Official Title
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The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery

Conditions
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Aortic Stenosis, Coronary Heart Disease, Heart Failure

Intervention / Treatment
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* Drug: Glucose-insulin-potassium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe aortic stenosis Coronary artery disease associated with poor left ventricular function Parsonnet score >7 Exclusion Criteria: Dementia or inability to understand the study protocol Off-pump and emergent cardiac surgery Poorly controlled diabetes mellitus Severe renal insufficiency Abnormal liver function Child-Plugh - C Body Mass Index < 18 and > 35

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: 1<br>Administration of glucose-insulin-potassium | Drug: Glucose-insulin-potassium<br>* 20 IU of insulin and 10 mM of KCl mixed with 50 ml of 40% Glucose. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postcardiotomy ventricular dysfunction |  | 48h postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic cardiac function using transoesophageal echocardiography |  | intraoperative | 
| Hypo-/hyperglycemia Hypo-/hyperkaliemia |  | intraoperative | 
| Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke) |  | 48 postoperative | 
| Serum troponin and creatinine kinase |  | Intraoperative - 48 h postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Cardioprotection, Aortocoronary bypass graft, Aortic stenosis