Influence of levosimendan on organ dysfunction in patients with severely reduced left ventricular function undergoing cardiac surgery.
OBJECTIVE
Levosimendan is an inotropic drug with organ-protective properties due to its activation of mitochondrial K(ATP) channels. This prospective, randomized, double-blind, placebo-controlled study investigated whether administration of levosimendan prior to cardiopulmonary bypass could reduce organ dysfunction and influence subsequent secondary endpoints.


METHODS
Patients with left ventricular ejection fraction <30% scheduled for elective coronary artery bypass surgery (with or without valve surgery) received either levosimendan (12.5 mg, 0.1 µg kg(-1) per min; n = 17) or placebo (n = 16) central venous infusion, immediately after anaesthesia induction, as add-on medication to a goal-orientated treatment algorithm.


RESULTS
A total of 33 patients completed the study. There were no statistically significant differences in Sequential Organ Failure Assessment scores, survival, haemodynamic parameters, time to extubation, time in intensive care unit, need for haemodialysis or health-related quality-of-life at 6 months post operation. The levosimendan group compared with the placebo group had significantly lower use of epinephrine (35% versus 81%) and nitroglycerine (6% versus 44%) 24 h postoperation, and significantly less frequent serious adverse events (13% versus 47%).


CONCLUSIONS
These preliminary results show that timely perioperative levosimendan treatment is feasible, has a favourable safety profile safe and may help to prevent low cardiac output syndrome. However, organ function was not preserved. Further studies, using larger sample sizes, are required.
Department of Anaesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital of Basel, Basel, Switzerland.
Joachim
J
Erb
Department of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Torsten
T
Beutlhauser
Department of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Aarne
A
Feldheiser
Department of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Birgit
B
Schuster
Department of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Sascha
S
Treskatsch
Department of Cardiovascular Surgery, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Herko
H
Grubitzsch
Department of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany claudia.spies@charite.de.
Claudia
C
Spies
D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000187:drug effects; D009202:Cardiomyopathies / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002316:Cardiotonic Agents / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D017335:Enoximone / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006835:Hydrazones / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D009638:Norepinephrine / Q000627:therapeutic use; D011446:Prospective Studies; D011724:Pyridazines / Q000627:therapeutic use*; D000077464:Simendan; D013318:Stroke Volume / Q000187:drug effects; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000627:therapeutic use; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery
D002316:Cardiotonic Agents; D006835:Hydrazones; D011724:Pyridazines; D014662:Vasoconstrictor Agents; D000077464:Simendan; D017335:Enoximone; D009638:Norepinephrine
Levosimendan; Sequential Organ Failure Assessment; adverse events; cardiac surgery; organ dysfunction; reduced left ventricular function