title: [Retrospective descriptive study about the use of levosimendan in children undergoing surgical correction for congenital heart disease].
abstract: OBJECTIVE
  To describe the use of levosimendan for compassionate use in children undergoing surgery for congenital heart disease, as well as survival rates, and the variations in the haemodynamic and analytical variables studied.
  
  
  METHODS
  An observational retrospective descriptive study was performed, using a review of clinical histories, from May 2005 to January 2010. Haemodynamic and analytical variables pre- and post- levosimendan administration, drugs used, and their dosages, and any adverse reactions were recorded.
  
  
  RESULTS
  Forty two children, 38 of them undergoing surgical correction, between the ages of four days and 5.75 years (median 92 days) were included. The drug was infused on 46 occasions. Four children received two doses. The infusion rate was among 0.1 to 0.6 μg × kg⁻¹ × min⁻¹. Only one patient received a loading dose. In 15 administrations (32.6%), the same dose was maintained throughout the infusion period. In 19 cases (41.3%), the dose was increased or decreased according to the need for vasoactive support. In surgical patients, overall survival after 30 days of the administration, calculated using the Kaplan-Meier method, was 80%. Blood lactate levels were statistically associated with mortality (P<.001).
  
  
  CONCLUSIONS
  There were no uniform criteria for using levosimendan, and it was only used as a rescue drug. Overall survival was similar to that reported in adult clinical trials. Clinical trials also need to be carried out in paediatric patients to determine the role of levosimendan in surgical practice, in order to develop and establish a clinical protocol for its use in children.
authors.affiliation: Servicio de Farmacia, Hospital Universitario Virgen de la Arrixaca, Murcia, España. mafpe13@gmail.com
authors.forename: M A
authors.initials: MA
authors.lastname: Fernández de Palencia-Espinosa
authors.forename: M D
authors.initials: MD
authors.lastname: Cárceles-Barón
authors.forename: M J
authors.initials: MJ
authors.lastname: Blázquez-Álvarez
authors.forename: V
authors.initials: V
authors.lastname: Arocas-Casañ
authors.forename: A
authors.initials: A
authors.lastname: de la Rubia-Nieto
mesh_terms: D002316:Cardiotonic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002675:Child, Preschool; D015897:Comorbidity; D057176:Compassionate Use Trials; D003326:Coronary Circulation / Q000187:drug effects; D004314:Down Syndrome / Q000150:complications; D004341:Drug Evaluation; D005260:Female; D006330:Heart Defects, Congenital / Q000401:mortality / Q000601:surgery*; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006835:Hydrazones / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D007022:Hypotension / Q000139:chemically induced; D007223:Infant; D007231:Infant, Newborn; D053208:Kaplan-Meier Estimate; D008297:Male; D017202:Myocardial Ischemia / Q000517:prevention & control; D011183:Postoperative Complications / Q000401:mortality / Q000517:prevention & control*; D015221:Potassium Channels / Q000187:drug effects; D011724:Pyridazines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012189:Retrospective Studies; D016879:Salvage Therapy; D000077464:Simendan; D013610:Tachycardia / Q000139:chemically induced
chemical_list: D002316:Cardiotonic Agents; D006835:Hydrazones; D015221:Potassium Channels; D011724:Pyridazines; D000077464:Simendan