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

Christoph Ellenberger

Status: Completed

Conditions: Coronary Heart Disease; Heart Failure; Aortic Stenosis

Treatments: Drug: Glucose-insulin-potassium; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00788242

NAC 08-032

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Administration of glucose-insulin-potassium

Treatment:

Drug: Glucose-insulin-potassium

2

Placebo Comparator group

Treatment:

Drug: Placebo