Clinical trial NCT04635293: Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery
Official title: Preoperative Infusion of Levosimendan in High Risk Cardiac Surgery Patients: A Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Cardiac Failure
Cardiac Surgery
Inotropes
Ejection Fraction
Keywords: levosimendan
low output syndrome
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective
Primary purpose: PREVENTION

Brief summary: The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery

Detailed description: Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. Levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium.

The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* elective cardiac surgery
* cardiac surgery under cardiopulmonary bypass
* low ejection fraction (\<40%)

Exclusion Criteria:

* age \<18 years old
* urgent operation
* glomerular filtration rate\<30 ml/min
* hepatic dysfunction preoperatively
* side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration
* redo surgery

Primary outcomes:
measure: hours of mechanical ventilation
timeFrame: during stay in ICU, approximately 48 hours postoperatively
measure: vasopressor use in operating room
timeFrame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
measure: vasopressor use in ICU
timeFrame: during stay in ICU, approximately 48 hours postoperatively
measure: inotrope use in operating room
timeFrame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
measure: inotrope use in ICU
timeFrame: during stay in ICU, approximately 48 hours postoperatively
measure: incidence of arrhythmias
timeFrame: postoperatively, an average period of 7-10 days
measure: incidence of renal dysfunction
timeFrame: postoperatively, an average period of 7-10 days
measure: length of ICU stay
timeFrame: postoperatively, an average period of 7-10 days
measure: hospitalization time
timeFrame: postoperatively, up to 20 days after the operation
measure: incidence of death within the first 30 days after surgery
timeFrame: 30 days after surgery
measure: need of mechanical assist devices intraoperatively
timeFrame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days
measure: need of mechanical assist devices postoperatively
timeFrame: postoperatively, an average period of 7-10 days
measure: change from baseline in cardiac output (CO)
timeFrame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
measure: change from baseline in mean arterial pressure (MAP)
timeFrame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
measure: change from baseline in mean pulmonary arterial pressure (MPAP)
timeFrame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
measure: change from baseline in systemic vascular resistance (SVR)
timeFrame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
measure: change from baseline in pulmonary vascular resistance (PVR)
timeFrame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
measure: change from baseline in pulmonary capillary wedge pressure (PCWP)
timeFrame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery),12 hours after ICU admittance, 24 hours after ICU admittance,
measure: change from baseline in cardiac function
timeFrame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.
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citation: Kivikko M, Lehtonen L. Levosimendan: a new inodilatory drug for the treatment of decompensated heart failure. Curr Pharm Des. 2005;11(4):435-55. doi: 10.2174/1381612053382043.
citation: Mehta RH, Leimberger JD, van Diepen S, Meza J, Wang A, Jankowich R, Harrison RW, Hay D, Fremes S, Duncan A, Soltesz EG, Luber J, Park S, Argenziano M, Murphy E, Marcel R, Kalavrouziotis D, Nagpal D, Bozinovski J, Toller W, Heringlake M, Goodman SG, Levy JH, Harrington RA, Anstrom KJ, Alexander JH; LEVO-CTS Investigators. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2032-2042. doi: 10.1056/NEJMoa1616218. Epub 2017 Mar 19.
citation: Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Levy F, Squara P, Ait Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasche P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.
citation: Papp Z, Edes I, Fruhwald S, De Hert SG, Salmenpera M, Leppikangas H, Mebazaa A, Landoni G, Grossini E, Caimmi P, Morelli A, Guarracino F, Schwinger RH, Meyer S, Algotsson L, Wikstrom BG, Jorgensen K, Filippatos G, Parissis JT, Gonzalez MJ, Parkhomenko A, Yilmaz MB, Kivikko M, Pollesello P, Follath F. Levosimendan: molecular mechanisms and clinical implications: consensus of experts on the mechanisms of action of levosimendan. Int J Cardiol. 2012 Aug 23;159(2):82-7. doi: 10.1016/j.ijcard.2011.07.022. Epub 2011 Jul 23.