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Drugs R D ; 21(1): 79-89, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33367965

RESUMEN

OBJECTIVE: 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. Trial registry number: EudraCT 2012-005310-19.


Asunto(s)
Puente Cardiopulmonar/efectos adversos , Cardiotónicos/farmacología , Cardiopatías Congénitas/cirugía , Lesiones Cardíacas/prevención & control , Hemodinámica/efectos de los fármacos , Simendán/farmacología , Biomarcadores/sangre , Puente Cardiopulmonar/métodos , Cardiotónicos/administración & dosificación , Preescolar , Método Doble Ciego , Femenino , Lesiones Cardíacas/sangre , Lesiones Cardíacas/etiología , Humanos , Lactante , Infusiones Intravenosas , Unidades de Cuidado Intensivo Pediátrico , Ácido Láctico/sangre , Tiempo de Internación , Masculino , Péptido Natriurético Encefálico/sangre , Péptido Natriurético Encefálico/efectos de los fármacos , Oxígeno/sangre , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Cuidados Preoperatorios/métodos , Respiración Artificial , Simendán/administración & dosificación , Tasa de Supervivencia , Troponina I/sangre , Troponina I/efectos de los fármacos
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