Myocardial Stunning
Conditions
Brief summary
Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. Colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution. The investigators hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.
Interventions
DRUGlevosimendan
infusion; levosimendan (12 μg/kg) The study drug will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient)
DRUGVitamin B 12
Infusion made of Glucos B.Braun 50 mg/ml infusion together with vitamin B12 which is used to colour the glucose infusion to look identical to Simdax infusion The placebo will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient).
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* preoperative LVEF 40% or less * septal wall thickness more than 11mm * less than moderate aortic insufficiency * sinus rhythm before CPB
Exclusion criteria
* oesophageal disease * known allergy to levosimendan or its metabolites or adjuvants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in cardiac output | from baseline to 15min after weaning from CPB | Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EF | from baseline to 5 min after sternal closure | Secondary endpoint is a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure. |
| cTnT/CK-MB on the first postoperative morning. | from baseline to 1st post. op. morning | Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning. |
Countries
Finland
Outcome results
None listed