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

This study has been completed.
Information provided by (Responsible Party):
Christoph Ellenberger, University Hospital, Geneva Identifier:
First received: November 7, 2008
Last updated: November 22, 2016
Last verified: November 2016
The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.

Condition Intervention
Aortic Stenosis Coronary Heart Disease Heart Failure Drug: Glucose-insulin-potassium Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Christoph Ellenberger, University Hospital, Geneva:

Primary Outcome Measures:
  • Postcardiotomy ventricular dysfunction [ Time Frame: 48h postoperative ]

Secondary Outcome Measures:
  • Systolic and diastolic cardiac function using transoesophageal echocardiography [ Time Frame: intraoperative ]
  • Hypo-/hyperglycemia Hypo-/hyperkaliemia [ Time Frame: intraoperative ]
  • Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke) [ Time Frame: 48 postoperative ]
  • Serum troponin and creatinine kinase [ Time Frame: Intraoperative - 48 h postoperative ]

Enrollment: 200
Study Start Date: January 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Administration of glucose-insulin-potassium
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 Comparator: 2 Drug: Placebo
60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00788242

Lugano, Ticino, Switzerland, 6900
Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
Christoph Ellenberger
  More Information

Responsible Party: Christoph Ellenberger, Médecin Adjoint, University Hospital, Geneva Identifier: NCT00788242     History of Changes
Other Study ID Numbers: NAC 08-032
Study First Received: November 7, 2008
Last Updated: November 22, 2016

Keywords provided by Christoph Ellenberger, University Hospital, Geneva:
Cardiac surgery
Aortocoronary bypass graft
Aortic stenosis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Aortic Valve Stenosis
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 19, 2017