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

This study is currently recruiting participants.
Verified April 2012 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Christoph Ellenberger, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00788242
First received: November 7, 2008
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Serum troponin and creatinine kinase [ Time Frame: Intraoperative - 48 h postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic and diastolic cardiac function using transoesophageal echocardiography [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Hypo-/hyperglycemia Hypo-/hyperkaliemia [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
  • Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke) [ Time Frame: 48 postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Primary Completion Date: December 2012 (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 two 60 min periods: before aortic cross-clamping and after aortic unclamping
Placebo Comparator: 2 Drug: Placebo
60 ml of isotonic saline. Administration of 0.8 ml/kg/h over two 60 min periods: before aortic cross-clamping and after aortic unclamping

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe aortic stenosis
  • Coronary artery disease associated with poor left ventricular function

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788242

Contacts
Contact: Christoph Ellenberger, MD 0041 22 3723311 Christoph.Ellenberger@hcuge.ch
Contact: Marc-Joseph Licker, MD 0041 22 3723311 Marc-Joseph.Licker@hcuge.ch

Locations
Switzerland
Cardiocentro Recruiting
Lugano, Ticino, Switzerland, 6900
Contact: Tiziano Cassina, MD     0041 91 8053111        
Principal Investigator: Ticiano Cassina, MD            
Geneva University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Christoph Ellenberger, MD     0041 22 3723311     Christoph.Ellenberger@hcuge.ch    
Contact: Marc-Joseph Licker, MD     0041 22 3723311     Marc-Joseph.Licker@hcuge.ch    
Principal Investigator: Christoph Ellenberger, MD            
Principal Investigator: Marc-Joseph Licker, MD            
Sub-Investigator: Yann Villiger, MD            
Sub-Investigator: John Diaper, RA            
Sponsors and Collaborators
Christoph Ellenberger
  More Information

No publications provided

Responsible Party: Christoph Ellenberger, Médecin Adjoint, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00788242     History of Changes
Other Study ID Numbers: NAC 08-032
Study First Received: November 7, 2008
Last Updated: April 13, 2012
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Failure
Heart Valve Diseases
Cardiovascular Diseases
 Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013