Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intracoronary Administration of Levosimendan in Cardiac Surgery Patients|
- change in cardiac output [ Time Frame: from baseline to 15min after weaning from CPB ] [ Designated as safety issue: No ]Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).
- EF [ Time Frame: from baseline to 5 min after sternal closure ] [ Designated as safety issue: No ]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. [ Time Frame: from baseline to 1st post. op. morning ] [ Designated as safety issue: No ]Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: levosimendan||
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)
|Placebo Comparator: placebo||
Drug: Vitamin 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).
Other Name: Soluvit (B05XC)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500785
|Contact: Panu Virkkala, MDemail@example.com|
|Heart Center Co. Tampere university hospital||Recruiting|
|Tampere, Finland, 33521|
|Contact: Kati Peltomaki +358504361303 firstname.lastname@example.org|
|Principal Investigator: Panu Virkkala, MD|
|Principal Investigator:||Panu Virkkala, MD||Heart Center Co. Tampere university hospital|