Joachim Erb1, Torsten Beutlhauser2, Aarne Feldheiser2, Birgit Schuster2, Sascha Treskatsch2, Herko Grubitzsch3, Claudia Spies4. 1. Department of Anaesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital of Basel, Basel, Switzerland. 2. Department of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany. 3. Department of Cardiovascular Surgery, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany. 4. Department of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany claudia.spies@charite.de.
Abstract
OBJECTIVES: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. PATIENTS AND METHODS: Patients with left ventricular ejection fraction <30% scheduled forelective 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.
RCT Entities:
OBJECTIVES: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. PATIENTS AND 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.
Authors: S Treskatsch; F Balzer; F Knebel; M Habicher; J P Braun; M Kastrup; H Grubitzsch; K-D Wernecke; C Spies; M Sander Journal: Int J Cardiovasc Imaging Date: 2015-06-06 Impact factor: 2.357
Authors: M Habicher; T Zajonz; M Heringlake; A Böning; S Treskatsch; U Schirmer; A Markewitz; M Sander Journal: Anaesthesist Date: 2018-05 Impact factor: 1.041
Authors: Julia Schumann; Eva C Henrich; Hellen Strobl; Roland Prondzinsky; Sophie Weiche; Holger Thiele; Karl Werdan; Stefan Frantz; Susanne Unverzagt Journal: Cochrane Database Syst Rev Date: 2018-01-29
Authors: Meaghan Lunney; Marinella Ruospo; Patrizia Natale; Robert R Quinn; Paul E Ronksley; Ioannis Konstantinidis; Suetonia C Palmer; Marcello Tonelli; Giovanni Fm Strippoli; Pietro Ravani Journal: Cochrane Database Syst Rev Date: 2020-02-27
Authors: Filippo Sanfilippo; Joshua B Knight; Sabino Scolletta; Cristina Santonocito; Federico Pastore; Ferdinando L Lorini; Luigi Tritapepe; Andrea Morelli; Antonio Arcadipane Journal: Crit Care Date: 2017-10-19 Impact factor: 9.097