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Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

Primary Purpose

Cardiac Disease, Cardiac Failure, Cardiac Surgery

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

preoperative infusion of levosimendan

no preoperative infusion of levosimendan

About this trial

This is an interventional prevention trial for Cardiac Disease focused on measuring levosimendan, low output syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Onassis Cardiac Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

patients who were not administered levosimendan prior to surgery

Arm Description

Outcomes

Primary Outcome Measures

hours of mechanical ventilation

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

vasopressor use in operating room

need for vasopressor use, yes or no

vasopressor use in ICU

need for vasopressor use, yes or no

inotrope use in operating room

need for inotrope use, yes or no

inotrope use in ICU

need for inotrope use, yes or no

incidence of arrhythmias

development of new-onset arrhythmias, yes or no

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

length of ICU stay

duration of patient stay in ICU in days

hospitalization time

duration of hospital stay after surgery in days

incidence of death within the first 30 days after surgery

patient survival within the first 30 days after surgery, yes or no

need of mechanical assist devices intraoperatively

need for mechanical assist devices, yes or no

need of mechanical assist devices postoperatively

need for mechanical assist devices, yes or no

change from baseline in cardiac output (CO)

a Swan-Ganz catheter will be used for hemodynamic measurements

change from baseline in mean arterial pressure (MAP)

a Swan-Ganz catheter will be used for hemodynamic measurements

change from baseline in mean pulmonary arterial pressure (MPAP)

a Swan-Ganz catheter will be used for hemodynamic measurements

change from baseline in systemic vascular resistance (SVR)

a Swan-Ganz catheter will be used for hemodynamic measurements

change from baseline in pulmonary vascular resistance (PVR)

a Swan-Ganz catheter will be used for hemodynamic measurements

change from baseline in pulmonary capillary wedge pressure (PCWP)

a Swan-Ganz catheter will be used for hemodynamic measurements

change from baseline in cardiac function

transesophageal echocardiography will be used for echocardiographic measurements

Secondary Outcome Measures

Full Information

NCT ID

NCT04635293

First Posted

November 9, 2020

Last Updated

November 12, 2020

Sponsor

Aretaieion University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04635293

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2012 (Actual)

Primary Completion Date

November 9, 2020 (Actual)

Study Completion Date

November 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aretaieion University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Disease, Cardiac Failure, Cardiac Surgery, Inotropes, Ejection Fraction

Keywords

levosimendan, low output syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Retrospective

Masking

ParticipantOutcomes Assessor

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Title

patients who were not administered levosimendan prior to surgery

Arm Type

Placebo Comparator

Intervention Type

Procedure

Intervention Name(s)

preoperative infusion of levosimendan

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

no preoperative infusion of levosimendan

Intervention Description

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

Primary Outcome Measure Information:

Title

hours of mechanical ventilation

Description

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

Time Frame

during stay in ICU, approximately 48 hours postoperatively

Title

vasopressor use in operating room

Description

need for vasopressor use, yes or no

Time Frame

intraoperatively, from induction to end of anesthesia, an average period of 3 hours

Title

vasopressor use in ICU

Description

need for vasopressor use, yes or no

Time Frame

during stay in ICU, approximately 48 hours postoperatively

Title

inotrope use in operating room

Description

need for inotrope use, yes or no

Time Frame

intraoperatively, from induction to end of anesthesia, an average period of 3 hours

Title

inotrope use in ICU

Description

need for inotrope use, yes or no

Time Frame

during stay in ICU, approximately 48 hours postoperatively

Title

incidence of arrhythmias

Description

development of new-onset arrhythmias, yes or no

Time Frame

postoperatively, an average period of 7-10 days

Title

incidence of renal dysfunction

Description

development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values

Time Frame

postoperatively, an average period of 7-10 days

Title

length of ICU stay

Description

duration of patient stay in ICU in days

Time Frame

postoperatively, an average period of 7-10 days

Title

hospitalization time

Description

duration of hospital stay after surgery in days

Time Frame

postoperatively, up to 20 days after the operation

Title

incidence of death within the first 30 days after surgery

Description

patient survival within the first 30 days after surgery, yes or no

Time Frame

30 days after surgery

Title

need of mechanical assist devices intraoperatively

Description

need for mechanical assist devices, yes or no

Time Frame

intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days

Title

need of mechanical assist devices postoperatively

Description

need for mechanical assist devices, yes or no

Time Frame

postoperatively, an average period of 7-10 days

Title

change from baseline in cardiac output (CO)

Description

a Swan-Ganz catheter will be used for hemodynamic measurements

Time Frame

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,

Title

change from baseline in mean arterial pressure (MAP)

Description

a Swan-Ganz catheter will be used for hemodynamic measurements

Time Frame

Title

change from baseline in mean pulmonary arterial pressure (MPAP)

Description

a Swan-Ganz catheter will be used for hemodynamic measurements

Time Frame

Title

change from baseline in systemic vascular resistance (SVR)

Description

a Swan-Ganz catheter will be used for hemodynamic measurements

Time Frame

Title

change from baseline in pulmonary vascular resistance (PVR)

Description

a Swan-Ganz catheter will be used for hemodynamic measurements

Time Frame

Title

change from baseline in pulmonary capillary wedge pressure (PCWP)

Description

a Swan-Ganz catheter will be used for hemodynamic measurements

Time Frame

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,

Title

change from baseline in cardiac function

Description

transesophageal echocardiography will be used for echocardiographic measurements

Time Frame

10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kassiani Theodoraki, PhD, DESA

Organizational Affiliation

Aretaieion University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Onassis Cardiac Surgery Center

City

Athens

ZIP/Postal Code

17674

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17702589

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. Erratum In: Eur J Cardiothorac Surg. 2008 Mar;33(3):521.

Results Reference

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PubMed Identifier

21963578

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.

Results Reference

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PubMed Identifier

19151048

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.

Results Reference

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PubMed Identifier

17377079

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. doi: 10.1213/01.ane.0000256863.92050.d3. Erratum In: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text.

Results Reference

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PubMed Identifier

15725064

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.

Results Reference

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PubMed Identifier

28316276

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.

Results Reference

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PubMed Identifier

28787507

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.

Results Reference

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PubMed Identifier

21784540

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.

Results Reference

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Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

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