Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
|ClinicalTrials.gov Identifier: NCT01500785|
Recruitment Status : Unknown
Verified April 2014 by Tampere University Hospital.
Recruitment status was: Recruiting
First Posted : December 28, 2011
Last Update Posted : April 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Stunning||Drug: levosimendan Drug: Vitamin B 12||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intracoronary Administration of Levosimendan in Cardiac Surgery Patients|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
|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)
- change in cardiac output [ Time Frame: 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).
- EF [ Time Frame: 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. [ Time Frame: from baseline to 1st post. op. morning ]Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500785
|Contact: Panu Virkkala, MDfirstname.lastname@example.org|
|Heart Center Co. Tampere university hospital||Recruiting|
|Tampere, Finland, 33521|
|Contact: Kati Peltomaki +358504361303 email@example.com|
|Principal Investigator: Panu Virkkala, MD|
|Principal Investigator:||Panu Virkkala, MD||Heart Center Co. Tampere university hospital|