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NCT Number: NCT04635293

Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onassis Cardiac Surgery Center

Athens, 17674, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. hours of mechanical ventilation

    Time frame: during stay in ICU, approximately 48 hours postoperatively

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

  2. vasopressor use in operating room

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

    need for vasopressor use, yes or no

  3. vasopressor use in ICU

    Time frame: during stay in ICU, approximately 48 hours postoperatively

    need for vasopressor use, yes or no

  4. inotrope use in operating room

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

    need for inotrope use, yes or no

  5. inotrope use in ICU

    Time frame: during stay in ICU, approximately 48 hours postoperatively

    need for inotrope use, yes or no

  6. incidence of arrhythmias

    Time frame: postoperatively, an average period of 7-10 days

    development of new-onset arrhythmias, yes or no

  7. incidence of renal dysfunction

    Time frame: postoperatively, an average period of 7-10 days

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

  8. length of ICU stay

    Time frame: postoperatively, an average period of 7-10 days

    duration of patient stay in ICU in days

  9. hospitalization time

    Time frame: postoperatively, up to 20 days after the operation

    duration of hospital stay after surgery in days

  10. incidence of death within the first 30 days after surgery

    Time frame: 30 days after surgery

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

  11. need of mechanical assist devices intraoperatively

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

    need for mechanical assist devices, yes or no

  12. need of mechanical assist devices postoperatively

    Time frame: postoperatively, an average period of 7-10 days

    need for mechanical assist devices, yes or no

  13. change from baseline in cardiac output (CO)

    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,

    a Swan-Ganz catheter will be used for hemodynamic measurements

  14. change from baseline in mean arterial pressure (MAP)

    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,

    a Swan-Ganz catheter will be used for hemodynamic measurements

  15. change from baseline in mean pulmonary arterial pressure (MPAP)

    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,

    a Swan-Ganz catheter will be used for hemodynamic measurements

  16. change from baseline in systemic vascular resistance (SVR)

    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,

    a Swan-Ganz catheter will be used for hemodynamic measurements

  17. change from baseline in pulmonary vascular resistance (PVR)

    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,

    a Swan-Ganz catheter will be used for hemodynamic measurements

  18. change from baseline in pulmonary capillary wedge pressure (PCWP)

    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,

    a Swan-Ganz catheter will be used for hemodynamic measurements

  19. change from baseline in cardiac function

    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)

    transesophageal echocardiography will be used for echocardiographic measurements

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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