Clinical trial NCT00788242: The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery
Official title: The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Coronary Heart Disease
Heart Failure
Keywords: Cardiac surgery
Cardioprotection
Aortocoronary bypass graft
Aortic stenosis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2008-11-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postcardiotomy ventricular dysfunction
timeFrame: 48h postoperative
Secondary outcomes:
measure: Systolic and diastolic cardiac function using transoesophageal echocardiography
timeFrame: intraoperative
measure: Hypo-/hyperglycemia Hypo-/hyperkaliemia
timeFrame: intraoperative
measure: Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)
timeFrame: 48 postoperative
measure: Serum troponin and creatinine kinase
timeFrame: Intraoperative - 48 h postoperative
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Cardiocentro
state: Ticino
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
References:
citation: Licker M, Diaper J, Sologashvili T, Ellenberger C. Glucose-insulin-potassium improves left ventricular performances after aortic valve replacement: a secondary analysis of a randomized controlled trial. BMC Anesthesiol. 2019 Sep 6;19(1):175. doi: 10.1186/s12871-019-0845-0.