Aortic Stenosis, Coronary Heart Disease, Heart Failure
Conditions
Keywords
Cardiac surgery, Cardioprotection, Aortocoronary bypass graft, Aortic stenosis
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.
Interventions
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
DRUGPlacebo
60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
Sponsors
Christoph Ellenberger
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postcardiotomy ventricular dysfunction | 48h postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Systolic and diastolic cardiac function using transoesophageal echocardiography | intraoperative |
| Hypo-/hyperglycemia Hypo-/hyperkaliemia | intraoperative |
| Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke) | 48 postoperative |
| Serum troponin and creatinine kinase | Intraoperative - 48 h postoperative |
Countries
Switzerland
Outcome results
None listed