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dc.contributor.authorAbril-Molina, Ana
dc.contributor.authorGómez Luque, José María
dc.contributor.authorPerín, Francesca
dc.contributor.authorEsteban-Molina, María
dc.contributor.authorFerreiro‑Marzal, Andrea
dc.contributor.authorFernández-Guerrero, Cristina
dc.contributor.authorOcete Hita, Esther 
dc.date.accessioned2021-02-12T08:24:15Z
dc.date.available2021-02-12T08:24:15Z
dc.date.issued2020-12-24
dc.identifier.citationAbril-Molina, A., Gómez-Luque, J.M., Perin, F. et al. Effect of Preoperative Infusion of Levosimendan on Biomarkers of Myocardial Injury and Haemodynamics After Paediatric Cardiac Surgery: A Randomised Controlled Trial. Drugs R D (2020). [https://doi.org/10.1007/s40268-020-00332-1]es_ES
dc.identifier.urihttp://hdl.handle.net/10481/66486
dc.descriptionTrial registry number: EudraCT 2012-005310-19.es_ES
dc.descriptionKey Points A randomised controlled trial was conducted to test the hypothesis that preoperative infusion of levosimendan would decrease myocardial injury biomarkers (troponin I and B-type natriuretic peptide) after paediatric cardiac surgery more efficiently than placebo. Troponin I and B-type natriuretic peptide levels were higher with placebo at 12 and 24 h after cardiopulmonary bypass, but the differences were not statistically significant. Lactic acid level was significantly lower and oxygen delivery (DO2) was significantly higher at 12 and 24 h after surgery in Levosimendan group. The results highlight the importance of this new drug and its possible benefit with regard to myocardial injury; however, evaluation in larger, adequately powered trials is needed to determine the efficacy of levosimendan.es_ES
dc.description.abstractObjective The aim was to test the hypothesis that preoperative infusion of levosimendan would decrease patients’ cardiac biomarker profiles during the immediate postoperative stage (troponin I and B-type natriuretic peptide levels) more efficiently than placebo after cardiopulmonary bypass. Methods In a randomised, placebo-controlled, double-blinded study, 30 paediatric patients were scheduled for congenital heart disease surgery. 15 patients (50%) received prophylactic levosimendan and 15 patients (50%) received placebo from 12 h before cardiopulmonary bypass to 24 h after surgery. Results Troponin I levels were higher in the placebo group at 0, 12, and 24 h after cardiopulmonary bypass, although the mean differences between the study groups and the 95% confidence intervals (CIs) for troponin I levels did not present statistically significant differences at any of the three time points considered (mean differences [95% CIs] − 3.32 pg/ml [− 19.34 to 12.70], − 2.42 pg/ml [− 19.78 to 13.95], and − 79.94 pg/ml [− 266.99 to 16.39] at 0, 12, and 24 h, respectively). A similar lack of statistically significant difference was observed for B-type natriuretic peptide (mean differences [95% CIs] 36.86 pg/dl [− 134.16 to 225.64], − 350.79 pg/dl [− 1459.67 to 557.45], and − 310.35 pg/dl [− 1505.76 to 509.82]). Lactic acid levels were significantly lower with levosimendan; the mean differences between the study groups and the 95% CIs for lactate levels present statistically significant differences at 0 h (− 1.52 mmol/l [− 3.19 to − 0.25]) and 12 h (− 1.20 mmol/l [− 2.53 to − 0.10]) after cardiopulmonary bypass. Oxygen delivery (DO2) was significantly higher at 12 h and 24 h after surgery (mean difference [95% CI] 627.70 ml/min/m2 [122.34–1162.67] and 832.35 ml/min/m2 [58.15 to 1651.38], respectively). Conclusions Levosimendan does not significantly improve patients’ postoperative troponin I and B-type natriuretic peptide profiles during the immediate postoperative stage in comparison with placebo, although both were numerically higher with placebo. Levosimendan, however, significantly reduced lactic acid levels and improved patients’ DO2 profiles. These results highlight the importance of this new drug and its possible benefit with regard to myocardial injury; however, evaluation in larger, adequately powered trials is needed to determine the efficacy of levosimendan.es_ES
dc.language.isoenges_ES
dc.publisherSpringer Naturees_ES
dc.rightsAtribución-NoComercial 3.0 España*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/es/*
dc.titleEffect of Preoperative Infusion of Levosimendan on Biomarkers of Myocardial Injury and Haemodynamics After Paediatric Cardiac Surgery: A Randomised Controlled Triales_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses_ES
dc.identifier.doi10.1007/s40268-020-00332-1
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersiones_ES


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