Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

NCT04635293 | Completed

• 1 other identifier: 667/24.02.2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Disease; Cardiac Failure; Cardiac Surgery; Inotropes; Ejection Fraction

Keywords

levosimendan; low output syndrome

Outcome Measures

Primary Outcomes (19)

• hours of mechanical ventilation

  hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU)

  during stay in ICU, approximately 48 hours postoperatively

• 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

• vasopressor use in ICU

  need for vasopressor use, yes or no

  during stay in ICU, approximately 48 hours postoperatively

• 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

• inotrope use in ICU

  need for inotrope use, yes or no

  during stay in ICU, approximately 48 hours postoperatively

• incidence of arrhythmias

  development of new-onset arrhythmias, yes or no

  postoperatively, an average period of 7-10 days

• 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

• length of ICU stay

  duration of patient stay in ICU in days

  postoperatively, an average period of 7-10 days

• hospitalization time

  duration of hospital stay after surgery in days

  postoperatively, up to 20 days after the operation

• 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

• 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

• need of mechanical assist devices postoperatively

  need for mechanical assist devices, yes or no

  postoperatively, an average period of 7-10 days

• 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,

• 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,

• 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,

• 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,

• 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,

• 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,

• 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)

Study Arms (2)

patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery

ACTIVE COMPARATOR

Procedure: preoperative infusion of levosimendan

patients who were not administered levosimendan prior to surgery

PLACEBO COMPARATOR

Procedure: no preoperative infusion of levosimendan

Interventions

preoperative infusion of levosimendan PROCEDURE

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

patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery

no preoperative infusion of levosimendan PROCEDURE

the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively

patients who were not administered levosimendan prior to surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Onassis Cardiac Surgery Center

Athens, 17674, Greece

Location

Related Publications (8)

• 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.

  PMID: 17702589 BACKGROUND

• 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.

  PMID: 21963578 BACKGROUND

• 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.

  PMID: 19151048 BACKGROUND

• 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. doi: 10.1213/01.ane.0000256863.92050.d3.

  PMID: 17377079 BACKGROUND

• 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.

  PMID: 15725064 BACKGROUND

• 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.

  PMID: 28316276 BACKGROUND

• 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.

  PMID: 28787507 BACKGROUND

• 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.

  PMID: 21784540 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Kassiani Theodoraki, PhD, DESA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Retrospective

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 19, 2020
• Study Start: January 1, 2012
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)