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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00788242
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):
Christoph Ellenberger, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Coronary Heart Disease Heart Failure Drug: Glucose-insulin-potassium Drug: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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

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

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

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00788242

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

Responsible Party: Christoph Ellenberger, Médecin Adjoint, University Hospital, Geneva Identifier: NCT00788242     History of Changes
Other Study ID Numbers: NAC 08-032
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 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