Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery

Study Overview
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Brief Summary
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Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an adjuvant therapy in patients with myocardial infarction or in the patients undergoing valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known to prevent excretion of lactate and to increase the extraction of lactate after reperfusion with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury of myocardium after CPB, to improve myocardial contractility, insulin resistance and hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.

Conditions
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Valvular Heart Disease

Intervention / Treatment
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* Drug: (Glucose-Insulin-Potassium)GIK group
* Drug: normal saline group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features: congestive heart failure infective endocarditis redo valvular surgery surgery combined with coronary bypass graft multiple valvular surgery expected CPB duration longer than 2 hr 7> preoperative serum creatinine over 1.4 mg/dl 8> preoperative hemoglobin level less than 12 mg/dl 9> left ventricular ejection fraction less than 40% Exclusion Criteria: emergency surgery hemodynamic instability before surgery (mean arterial pressure < 60 mmHg, heart rate >100 /min need for pharmacological or mechanical assist for hemodynamic stability before surgery baseline blood lactate level more than 2 mmol/l on steroid or NSAID hepatic dysfunction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Glucose-Insulin-Potassium)GIK group<br>infusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery | Drug: (Glucose-Insulin-Potassium)GIK group<br>* infusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery<br>|
| Active Comparator: normal saline group<br>same rate of normal saline | Drug: normal saline group<br>* same rate of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative blood lactate level | Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group | change of blood lactate level for 10 time points (before induction of anesthesia, immediately after induction of anesthesia, pre-CPB, 15 min after CPB, ACC off, post-CPB, sternum closure, ICU admission, 3 h after ICU admission, POD 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIK, valvular heart surgery, lactate