Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Preoperative Infusion of Levosimendan in High Risk Cardiac Surgery Patients: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635293
• Other study ID #: 667/24.02.2020
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: November 9, 2020

Study information

• Verified date: November 2020
• Source: Aretaieion University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Failure
• Cardiac Surgery
• Ejection Fraction
• Heart Diseases
• Heart Failure
• Inotropes

Intervention

Procedure:
• preoperative infusion of levosimendan
the study group will consist of patients who have received a continuous infusion of levosimendan 0.1 µg/kg/min for 24 hours before cardiac surgery
• no preoperative infusion of levosimendan
the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively

Locations

Country	Name	City	State
Greece	Onassis Cardiac Surgery Center	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (8)

Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Lévy F, Squara P, Aït Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasché 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. — View Citation

De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. Erratum in: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text. — View 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. Review. — View Citation

Landoni G, Biondi-Zoccai G, Greco M, Greco T, Bignami E, Morelli A, Guarracino F, Zangrillo A. Effects of levosimendan on mortality and hospitalization. A meta-analysis of randomized controlled studies. Crit Care Med. 2012 Feb;40(2):634-46. doi: 10.1097/CCM.0b013e318232962a. Review. — View 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. — View Citation

Papp Z, Édes I, Fruhwald S, De Hert SG, Salmenperä M, Leppikangas H, Mebazaa A, Landoni G, Grossini E, Caimmi P, Morelli A, Guarracino F, Schwinger RH, Meyer S, Algotsson L, Wikström BG, Jörgensen K, Filippatos G, Parissis JT, González 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. Review. — View 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. Epub 2007 Aug 15. Erratum in: Eur J Cardiothorac Surg. 2008 Mar;33(3):521. — View Citation

Tritapepe L, De Santis V, Vitale D, Guarracino F, Pellegrini F, Pietropaoli P, Singer M. Levosimendan pre-treatment improves outcomes in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2009 Feb;102(2):198-204. doi: 10.1093/bja/aen367. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hours of mechanical ventilation	hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU)	during stay in ICU, approximately 48 hours postoperatively
Primary	vasopressor use in operating room	need for vasopressor use, yes or no	intraoperatively, from induction to end of anesthesia, an average period of 3 hours
Primary	vasopressor use in ICU	need for vasopressor use, yes or no	during stay in ICU, approximately 48 hours postoperatively
Primary	inotrope use in operating room	need for inotrope use, yes or no	intraoperatively, from induction to end of anesthesia, an average period of 3 hours
Primary	inotrope use in ICU	need for inotrope use, yes or no	during stay in ICU, approximately 48 hours postoperatively
Primary	incidence of arrhythmias	development of new-onset arrhythmias, yes or no	postoperatively, an average period of 7-10 days
Primary	incidence of renal dysfunction	development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values	postoperatively, an average period of 7-10 days
Primary	length of ICU stay	duration of patient stay in ICU in days	postoperatively, an average period of 7-10 days
Primary	hospitalization time	duration of hospital stay after surgery in days	postoperatively, up to 20 days after the operation
Primary	incidence of death within the first 30 days after surgery	patient survival within the first 30 days after surgery, yes or no	30 days after surgery
Primary	need of mechanical assist devices intraoperatively	need for mechanical assist devices, yes or no	intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days
Primary	need of mechanical assist devices postoperatively	need for mechanical assist devices, yes or no	postoperatively, an average period of 7-10 days
Primary	change from baseline in cardiac output (CO)	a Swan-Ganz catheter will be used for hemodynamic measurements	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,
Primary	change from baseline in mean arterial pressure (MAP)	a Swan-Ganz catheter will be used for hemodynamic measurements	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,
Primary	change from baseline in mean pulmonary arterial pressure (MPAP)	a Swan-Ganz catheter will be used for hemodynamic measurements	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,
Primary	change from baseline in systemic vascular resistance (SVR)	a Swan-Ganz catheter will be used for hemodynamic measurements	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,
Primary	change from baseline in pulmonary vascular resistance (PVR)	a Swan-Ganz catheter will be used for hemodynamic measurements	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,
Primary	change from baseline in pulmonary capillary wedge pressure (PCWP)	a Swan-Ganz catheter will be used for hemodynamic measurements	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,
Primary	change from baseline in cardiac function	transesophageal echocardiography will be used for echocardiographic measurements	10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)