Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

Study Overview
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Brief Summary
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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.

Official Title
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Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

Conditions
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Myocardial Stunning

Intervention / Treatment
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* Drug: levosimendan
* Drug: Vitamin B 12


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levosimendan<br> | Drug: levosimendan<br>* 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)<br>* Other names: CO1CX08;|
| Placebo Comparator: placebo<br> | Drug: Vitamin B 12<br>* 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).<br>* Other names: Soluvit (B05XC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cardiac output | Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia). | from baseline to 15min after weaning from CPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EF | Secondary endpoint is a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure. | from baseline to 5 min after sternal closure | 
| cTnT/CK-MB on the first postoperative morning. | Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning. | from baseline to 1st post. op. morning |