Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
Status:
Terminated
Trial end date:
2019-09-11
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Tampere University Hospital
Treatments:
Hydroxocobalamin Simendan Vitamin B 12 Vitamin B Complex Vitamins