Brief Title
The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery
Official Title
The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery
Brief Summary
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
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.
Study Type
Interventional
Primary Outcome
Postcardiotomy ventricular dysfunction
Secondary Outcome
Systolic and diastolic cardiac function using transoesophageal echocardiography
Condition
Aortic Stenosis
Intervention
Glucose-insulin-potassium
Study Arms / Comparison Groups
1
Description: Administration of glucose-insulin-potassium
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
200
Start Date
January 2009
Completion Date
December 2013
Primary Completion Date
December 2013
Eligibility Criteria
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
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT00788242
Organization ID
NAC 08-032
Responsible Party
Sponsor-Investigator
Study Sponsor
Christoph Ellenberger
Study Sponsor
, ,
Verification Date
November 2016