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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788242
• Other study ID #: NAC 08-032
• Status: Completed
• Phase: N/A
• First received: November 7, 2008
• Last updated: November 22, 2016
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Heart Failure
• Myocardial Ischemia

Intervention

Drug:
• Glucose-insulin-potassium
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
• Placebo
60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva
Switzerland	Cardiocentro	Lugano	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Christoph Ellenberger

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postcardiotomy ventricular dysfunction		48h postoperative	No
Secondary	Systolic and diastolic cardiac function using transoesophageal echocardiography		intraoperative	No
Secondary	Hypo-/hyperglycemia Hypo-/hyperkaliemia		intraoperative	Yes
Secondary	Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)		48 postoperative	No
Secondary	Serum troponin and creatinine kinase		Intraoperative - 48 h postoperative	No