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Estrés por hidrocortisona en shock séptico pediátrico: protocolo para un ensayo intervencionista pragmático,

Kusum Menon^1,2, Michael S D Agus^3,4, Katie O'Hearn²

¹Department of Pediatrics, Children's Hospital of Eastern Ontario, ON, Canada.

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

|January 8, 2026

Resumen

Este estudio investiga el uso de corticosteroides en el shock séptico pediátrico, una afección con alta mortalidad. Los resultados aclararán las pautas de tratamiento para esta enfermedad pediátrica crítica.

Área de la Ciencia:

Medicina de cuidados intensivos pediátricos
Enfermedad crítica pediátrica
Investigación en unidades de cuidados intensivos pediátricos (UCIP)

Sus antecedentes:

El shock séptico es una causa importante de ingreso en la unidad de cuidados intensivos pediátricos con alta morbilidad y mortalidad.
La evidencia actual sobre el uso de corticosteroides en el shock séptico pediátrico no es concluyente, lo que genera incertidumbre en el manejo clínico.
Las pautas existentes carecen de recomendaciones definitivas para la administración de corticosteroides en esta población de pacientes.

Objetivo del estudio:

Evaluar la eficacia y seguridad de la hidrocortisona en el tratamiento del shock séptico pediátrico.
Proporcionar datos sólidos para recomendaciones basadas en evidencia sobre el uso de corticosteroides en el shock séptico pediátrico.
Evaluar el impacto de los corticosteroides en el síndrome de disfunción multiorgánica y los resultados del paciente.

Principales métodos:

Un ensayo pragmático, multicéntrico, internacional, aleatorizado, doble ciego y controlado con placebo que involucra aproximadamente 50 UCI pediátricas.
Inscripción de hasta 500 pacientes pediátricos (1 mes a 17 años y 8 meses) diagnosticados con shock séptico.
Administración de hidrocortisona IV (bolo de 2 mg/kg, luego 1 mg/kg cada 6 horas) o placebo hasta que se suspendan las infusiones vasoactivas-inotrópicas durante 12 horas o durante un máximo de 7 días.

Principales resultados:

El resultado primario medido es la incidencia de síndrome de disfunción multiorgánica nuevo o progresivo en 28 días.
Los resultados secundarios incluyen el compuesto de muerte o una disminución significativa (≥25%) en la calidad de vida relacionada con la salud a los 28 días.
El estudio tiene la potencia para detectar diferencias clínicamente significativas en los resultados relacionados con el tratamiento con corticosteroides.

Conclusiones:

Este ensayo es el primer estudio pediátrico adecuadamente potenciado para evaluar los beneficios y riesgos de los corticosteroides en el shock séptico.
Los hallazgos del estudio informarán las futuras pautas de práctica clínica para el manejo del shock séptico pediátrico.
Los datos definitivos guiarán las decisiones sobre la administración de corticosteroides en niños críticamente enfermos con shock séptico.

Palabras clave:

niño hidrocortisona cuidados intensivos pediátricos sepsis séptico shock

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