Original Article
Hydrocortisone for the treatment of refractory hypotension: a randomised controlled trial
Hidrocortisona para el tratamiento de hipotensión refractaria: ensayo clínico controlado y aleatorizado
G. Salasa, M. Travagliantib, A. Leoneb, C. Couceiroa, S. Rodríguezc, D. Fariñaa,
Corresponding author
a Área de Terapia Intensiva Neonatal, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Ciudad Autónoma de Buenos Aires, Argentina
b Área de Farmacia, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Ciudad Autónoma de Buenos Aires, Argentina
c Docencia e Investigación, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Ciudad Autónoma de Buenos Aires, Argentina
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Garrahan, Ciudad Autónoma de Buenos Aires, Argentina" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Docencia e Investigación, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Ciudad Autónoma de Buenos Aires, Argentina" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Hidrocortisona para el tratamiento de hipotensión refractaria: ensayo clínico controlado y aleatorizado" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2013-01-10" "fechaAceptado" => "2013-08-26" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec330029" "palabras" => array:6 [ 0 => "Hydrocortisone" 1 => "Hypotension" 2 => "Inotropes" 3 => "Dopamine" 4 => "Epinephrine" 5 => "Steroids" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec330030" "palabras" => array:6 [ 0 => "Hidrocortisona" 1 => "Hipotensión" 2 => "Inotrópicos" 3 => "Dopamina" 4 => "Epinefrina" 5 => "Esteroides" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">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.</p> <span class="elsevierStyleSectionTitle" id="sect0015">Material and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">To assess the effectiveness of hydrocortisone in the reduction of inotropic support in infants with refractory hypotension. Population: infants who required dopamine ≥ 14<span class="elsevierStyleHsp" style=""></span>μg/kg/min and/or epinephrine.</p> <span class="elsevierStyleSectionTitle" id="sect0020">Design</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">prospective, controlled, randomised, double-blind trial with placebo.</p> <span class="elsevierStyleSectionTitle" id="sect0025">Intervention</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">HC: 2.5<span class="elsevierStyleHsp" style=""></span>mg/kg every 12<span class="elsevierStyleHsp" style=""></span>hours, for 48<span class="elsevierStyleHsp" style=""></span>hours intravenously (intervention group [IG]); placebo: isotonic saline 1.25<span class="elsevierStyleHsp" style=""></span>ml/kg/doses intravenously (placebo group [PG]) every 12<span class="elsevierStyleHsp" style=""></span>hours, for 48<span class="elsevierStyleHsp" style=""></span>hours. Randomisation was performed in blocks with blind assignment.</p> <span class="elsevierStyleSectionTitle" id="sect0030">Results</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">A total of 50 infants with refractory systemic hypotension were prospectively recruited. Patient characteristics were similar in both groups. Requirements for inotropic support at 48<span class="elsevierStyleHsp" style=""></span>hrs were achieved in 60% of the IG versus 24% of the PG <span class="elsevierStyleItalic">(P</span>=.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 <span class="elsevierStyleItalic">(P</span> =.008).</p> <span class="elsevierStyleSectionTitle" id="sect0035">Conclusion</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">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.</p>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0045">Introducción</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">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.</p> <span class="elsevierStyleSectionTitle" id="sect0050">Material y métodos</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Se incluyó a todos los RNT con requerimientos de dopamina ≥ 14<span class="elsevierStyleHsp" style=""></span>μg/k/ min y/o epinefrina.</p> <span class="elsevierStyleSectionTitle" id="sect0055">Diseño</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">prospectivo, controlado, aleatorizado, doble ciego con placebo.</p> <span class="elsevierStyleSectionTitle" id="sect0060">Intervención</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">HC: 2,5<span class="elsevierStyleHsp" style=""></span>mg/kg c/12<span class="elsevierStyleHsp" style=""></span>h, por 48<span class="elsevierStyleHsp" style=""></span>h por vía intravenosa (IV) (grupo intervención [GI]); placebo: solución fisiológica 1,25<span class="elsevierStyleHsp" style=""></span>ml/kg/dosis IV (grupo placebo [GP]). Se efectuó aleatorización en bloques con asignación oculta.</p> <span class="elsevierStyleSectionTitle" id="sect0065">Resultados</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Ingresaron al estudio 50 RNT con hipotensión refractaria. No se observaron diferencias significativas entre los 2 grupos. La reducción del soporte inotrópico a las 48<span class="elsevierStyleHsp" style=""></span>h 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).</p> <span class="elsevierStyleSectionTitle" id="sect0070">Conclusión</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">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.</p>" ] ] "NotaPie" => array:2 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">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.</p>" ] 1 => array:2 [ "etiqueta" => "☆☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">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. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 14 | 9 | 23 |
| 2024 October | 87 | 67 | 154 |
| 2024 September | 89 | 60 | 149 |
| 2024 August | 104 | 71 | 175 |
| 2024 July | 103 | 48 | 151 |
| 2024 June | 89 | 45 | 134 |
| 2024 May | 70 | 51 | 121 |
| 2024 April | 69 | 31 | 100 |
| 2024 March | 74 | 39 | 113 |
| 2024 February | 109 | 32 | 141 |
| 2024 January | 90 | 30 | 120 |
| 2023 December | 79 | 38 | 117 |
| 2023 November | 80 | 34 | 114 |
| 2023 October | 101 | 27 | 128 |
| 2023 September | 78 | 35 | 113 |
| 2023 August | 71 | 22 | 93 |
| 2023 July | 91 | 31 | 122 |
| 2023 June | 91 | 26 | 117 |
| 2023 May | 104 | 25 | 129 |
| 2023 April | 73 | 19 | 92 |
| 2023 March | 104 | 30 | 134 |
| 2023 February | 76 | 17 | 93 |
| 2023 January | 75 | 20 | 95 |
| 2022 December | 79 | 30 | 109 |
| 2022 November | 76 | 36 | 112 |
| 2022 October | 67 | 42 | 109 |
| 2022 September | 59 | 38 | 97 |
| 2022 August | 59 | 60 | 119 |
| 2022 July | 68 | 38 | 106 |
| 2022 June | 103 | 41 | 144 |
| 2022 May | 106 | 38 | 144 |
| 2022 April | 81 | 46 | 127 |
| 2022 March | 115 | 60 | 175 |
| 2022 February | 77 | 46 | 123 |
| 2022 January | 92 | 50 | 142 |
| 2021 December | 84 | 43 | 127 |
| 2021 November | 81 | 52 | 133 |
| 2021 October | 73 | 62 | 135 |
| 2021 September | 58 | 56 | 114 |
| 2021 August | 60 | 54 | 114 |
| 2021 July | 55 | 43 | 98 |
| 2021 June | 57 | 50 | 107 |
| 2021 May | 52 | 39 | 91 |
| 2021 April | 74 | 43 | 117 |
| 2021 March | 64 | 47 | 111 |
| 2021 February | 45 | 18 | 63 |
| 2021 January | 45 | 22 | 67 |
| 2020 December | 50 | 16 | 66 |
| 2020 November | 57 | 20 | 77 |
| 2020 October | 83 | 13 | 96 |
| 2020 September | 124 | 16 | 140 |
| 2020 August | 80 | 9 | 89 |
| 2020 July | 48 | 14 | 62 |
| 2020 June | 50 | 17 | 67 |
| 2020 May | 58 | 23 | 81 |
| 2020 April | 27 | 19 | 46 |
| 2020 March | 34 | 19 | 53 |
| 2020 February | 37 | 24 | 61 |
| 2020 January | 34 | 14 | 48 |
| 2019 December | 41 | 36 | 77 |
| 2019 November | 26 | 15 | 41 |
| 2019 October | 40 | 18 | 58 |
| 2019 September | 20 | 15 | 35 |
| 2019 August | 58 | 21 | 79 |
| 2019 July | 37 | 18 | 55 |
| 2019 June | 39 | 21 | 60 |
| 2019 May | 75 | 34 | 109 |
| 2019 April | 69 | 69 | 138 |
| 2019 March | 37 | 24 | 61 |
| 2019 February | 46 | 24 | 70 |
| 2019 January | 30 | 23 | 53 |
| 2018 December | 36 | 29 | 65 |
| 2018 November | 59 | 36 | 95 |
| 2018 October | 67 | 23 | 90 |
| 2018 September | 42 | 27 | 69 |
| 2018 August | 2 | 0 | 2 |
| 2018 June | 1 | 0 | 1 |
| 2018 May | 1 | 0 | 1 |
| 2018 April | 21 | 0 | 21 |
| 2018 March | 14 | 0 | 14 |
| 2018 February | 2 | 0 | 2 |
| 2018 January | 11 | 0 | 11 |
| 2017 December | 5 | 0 | 5 |
| 2017 November | 10 | 0 | 10 |
| 2017 October | 18 | 0 | 18 |
| 2017 September | 5 | 0 | 5 |
| 2017 August | 8 | 0 | 8 |
| 2017 July | 15 | 4 | 19 |
| 2017 June | 15 | 29 | 44 |
| 2017 May | 17 | 31 | 48 |
| 2017 April | 10 | 14 | 24 |
| 2017 March | 5 | 45 | 50 |
| 2017 February | 9 | 26 | 35 |
| 2017 January | 6 | 11 | 17 |
| 2016 December | 20 | 24 | 44 |
| 2016 November | 28 | 23 | 51 |
| 2016 October | 32 | 17 | 49 |
| 2016 September | 46 | 32 | 78 |
| 2016 August | 50 | 28 | 78 |
| 2016 July | 39 | 30 | 69 |
| 2016 March | 3 | 0 | 3 |
| 2015 December | 2 | 0 | 2 |
| 2015 November | 1 | 25 | 26 |
| 2015 October | 2 | 36 | 38 |
| 2015 September | 1 | 0 | 1 |
| 2015 July | 1 | 0 | 1 |
| 2015 January | 1 | 0 | 1 |
| 2014 December | 3 | 1 | 4 |
| 2014 November | 3 | 0 | 3 |
| 2014 October | 2 | 0 | 2 |
| 2014 September | 3 | 0 | 3 |
| 2014 August | 3 | 0 | 3 |
| 2014 July | 3 | 0 | 3 |
| 2014 June | 12 | 2 | 14 |
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