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

Not Applicable

Completed

• Conditions: Aortic Stenosis; Heart Failure; Coronary Heart Disease
• Interventions: Drug: Glucose-insulin-potassium; Drug: Placebo

• Registration Number: NCT00788242
• Lead Sponsor: Christoph Ellenberger

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 Timeline

• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Study Start: 2009-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Glucose-insulin-potassium	Administration of glucose-insulin-potassium
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Postcardiotomy ventricular dysfunction	48h postoperative

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Geneva University Hospital; 🇨🇭 Geneva, Switzerland

Cardiocentro; 🇨🇭 Lugano, Ticino, Switzerland