Hydrocortisone for the treatment of refractory hypotension: a randomised controlled trial

Salas, G.; Travaglianti, M.; Leone, A.; Couceiro, C.; Rodríguez, S.; Fariña, D.

doi:10.1016/j.anpede.2014.06.001

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Abstract

Introduction

Systemic hypotension is a common sign in critically sick infants. Several studies have suggested that the use of short series of corticosteroids increases arterial blood pressure and reduces the inotropic support needs in preterm neonates with hypotension. There are a small number of reports on the use of hydrocortisone (HC) for the treatment of refractory hypotension in infants.

Material and methods

To assess the effectiveness of hydrocortisone in the reduction of inotropic support in infants with refractory hypotension. Population: infants who required dopamine ≥ 14μg/kg/min and/or epinephrine.

Design

prospective, controlled, randomised, double-blind trial with placebo.

Intervention

HC: 2.5mg/kg every 12hours, for 48hours intravenously (intervention group [IG]); placebo: isotonic saline 1.25ml/kg/doses intravenously (placebo group [PG]) every 12hours, for 48hours. Randomisation was performed in blocks with blind assignment.

Results

A total of 50 infants with refractory systemic hypotension were prospectively recruited. Patient characteristics were similar in both groups. Requirements for inotropic support at 48hrs were achieved in 60% of the IG versus 24% of the PG (P=.009, RR: 2.5, 95% CI, 1.16-5.38). A significant association was observed between the administration of HC in infants treated with epinephrine and the presence of hyperglycaemia (P =.008).

Conclusion

In patients with refractory hypotension hydrocortisone administration reduced the need for inotropic support. Further studies with a greater number of patients are needed to confirm the effectiveness of HC as a therapeutic tool in these infants.

Keywords:

Hydrocortisone

Hypotension

Inotropes

Dopamine

Epinephrine

Steroids

Resumen

Introducción

La hipotensión arterial es un signo frecuente en recién nacidos críticamente enfermos. Varios estudios clínicos señalan que series cortas de corticoides aumentan la PA y disminuyen el requerimiento de inotrópicos en prematuros con hipotensión. Existe escaso número de estudios de empleo de hidrocortisona para el tratamiento de la hipotensión refractaria en recién nacidos (RNT). El objetivo de este estudio es evaluar la eficacia de la hidrocortisona (HC) para la reducción del soporte inotrópico en RNT con hipotensión arterial refractaria.

Material y métodos

Se incluyó a todos los RNT con requerimientos de dopamina ≥ 14μg/k/ min y/o epinefrina.

Diseño

prospectivo, controlado, aleatorizado, doble ciego con placebo.

Intervención

HC: 2,5mg/kg c/12h, por 48h por vía intravenosa (IV) (grupo intervención [GI]); placebo: solución fisiológica 1,25ml/kg/dosis IV (grupo placebo [GP]). Se efectuó aleatorización en bloques con asignación oculta.

Resultados

Ingresaron al estudio 50 RNT con hipotensión refractaria. No se observaron diferencias significativas entre los 2 grupos. La reducción del soporte inotrópico a las 48h en el GI se alcanzó en el 60% de los pacientes vs. el 24% en el GP (p = 0,009, RR = 2,5, IC del 95%, 1,16 a 5,38). Se observó una asociación significativa entre la administración de HC en RNT tratados con epinefrina y la presencia de hiperglucemia (p = 0,008).

Conclusión

La administración de HC en pacientes con hipotensión refractaria redujo la necesidad de soporte inotrópico. Estos datos contribuyen a continuar investigando acerca del papel de los esteroides en el soporte hemodinámico de pacientes críticos.

Palabras clave:

Hidrocortisona

Hipotensión

Inotrópicos

Dopamina

Epinefrina

Esteroides

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☆

Presented at the 46th meeting of the Sociedad Latinoamericana de Investigación Pediátrica [Latin American Association for Paediatric Research] 2008. Sociedad Iberoamericana de Neonatología [Ibero-American Society of Neonatology]. Cusco, Peru, September 2008.

☆☆

Please cite this article as: Salas G, Travaglianti M, Leone A, Couceiro C, Rodríguez S, Fariña D. Hidrocortisona para el tratamiento de hipotensión refractaria: ensayo clínico controlado y aleatorizado. An Pediatr (Barc). 2014;80(6):387-393.

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