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CP-091 Analysis of off-label use of levosimendan in paediatrics
  1. J Mateo Carmona,
  2. O García Molina,
  3. V Arocas Casañ,
  4. MA Fernández De Palencia Espinosa,
  5. M Valderrey Pulido,
  6. S Vicente Sánchez,
  7. A Tomás Luiz,
  8. MM Ruiz Jiménez,
  9. P De La Cruz Murie,
  10. M Galindo Rueda
  1. Hospital Clinico Universitario Virgen de La Arrixaca, Pharmacy, Murcia, Spain

Abstract

Background Levosimendan is a calcium sensitising inodilator agent that is indicated for the short term treatment of severe acute decompensation of chronic heart failure in situations where conventional therapy is not sufficient in adult patients. Levosimendan is used off-label in paediatric patients and we should develop and establish a clinical protocol for its use in children.

Purpose To analyse the use of levosimendan for off-label use in children for congenital heart disease and to determine the survival rate.

Material and methods An observational retrospective descriptive study was performed from October 2009 to April 2015. The following data were collected: age, diagnosis, dosage, analytical variables pre- and post-levosimendan administration and survival rate.

Results 23 patients were studied, between the ages of 1 day and 1.4 years, with a median age of 90 days (13.5–195.1).

Surgery with extracorporeal circulation was performed in 20 children. Those patients in whom no surgery was conducted (2) had heart failure refractory to vasoactive drugs and 1 had dilated cardiomyopathy.

The infusion rate was 0.05 to 0.6 g/kg/min. Three patients received a loading dose. One children received a second dose after a week of the first administration.

The average analytical parameters that improved in patients after levosimendan infusion were lactate, potassium, creatinine clearance and haemoglobin, but there were not statistically significant (p > 0.05).

4 of the 23 children who were treated with levosimendan died (17.4%).

Conclusion Levosimendan is used off-label in paediatric cardiac surgery. There were no statistically significant improvements in the analytical variables. However, in our data, survival rates were similar to those reported in other published studies.

References and/or Acknowledgements

  1. Silvetti S, et al. A systematic review on levosimendan in paediatric patients. Curr Vasc Pharmacol 2015;13:128-33

References and/or AcknowledgementsNo conflict of interest.

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