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Translation, Interpreting, Editing/proofreading, Website localization, Software localization, MT post-editing, Project management Specializes in: Business/Commerce (general) Certificates, Diplomas, Licenses, CVs Social Science, Sociology, Ethics, etc. Construction / Civil Engineering Education / Pedagogy General / Conversation / Greetings / Letters Insurance Medical: Health Care Medical (general) Military / Defense
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Spanish to English - Rates: 0.70 - 0.16 USD per word / 25 - 35 USD per hour English to Spanish - Rates: 0.70 - 0.16 USD per word / 25 - 35 USD per hour
PRO-level points: 4 , Questions answered: 9 , Questions asked: 7 40 projects entered 36 positive feedback from outsourcers Project Details Project Summary Corroboration Translation Volume: 3930 words Completed: Mar 2008 Languages:Spanish to English Two Divorce Decrees Law (general) positive Maria Alves : Accurate and within deadline Translation Volume: 1 pages Completed: Feb 2008 Languages:Spanish to English Translation of Website Page Education / Pedagogy positive Iwith : No comment. Translation Volume: 5 pages Completed: Jan 2008 Languages:Spanish to English 5 page medical document Medical: Health Care No comment. Translation Volume: 35 lines Completed: Jan 2008 Languages:Spanish to English Translation of Educational website link Education / Pedagogy positive Iwith : No comment. Translation Volume: 5 pages Completed: Dec 2007 Languages:Spanish to English 5 page Educational Transcripts and Certificates Education / Pedagogy positive Translation Experts : No comment. 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Translation Volume: 4 pages Completed: May 2007 Languages:Spanish to English Translation of a powerpoint presentation Education / Pedagogy positive Iwith : No comment. Translation Volume: 70 pages Completed: May 2007 Languages:English to Spanish Special Education Legal Documents Excellent company to work with. Great communication and prompt payment.Education / Pedagogy positive Cesa 6 : Outstanding work! Translation Volume: 3 pages Completed: May 2007 Languages:Spanish to English Translation from Spanish to English of 3 PDF files General / Conversation / Greetings / Letters positive Translation Experts : No comment. Translation Volume: 1800 words Completed: May 2007 Languages:Spanish to English Translation from Spanish to English of medical report and police document Excellent company to work with. Great communication!Medical (general), Law (general) No comment. Translation Volume: 1100 words Completed: May 2007 Languages:Spanish to English 2 birth certificates Certificates, Diplomas, Licenses, CVs positive Blue Board outsourcer (0 to 5 entries): No comment. Editing/proofreading Volume: 10 pages Completed: Apr 2007 Languages:English Ten page proofreading/editing of a manual Education / Pedagogy positive Iwith : No comment. Translation Volume: 500 words Completed: Apr 2007 Languages:Spanish to English Two birth certificates and one medical certificate Easy to work with. Great communication! Certificates, Diplomas, Licenses, CVs, Medical: Health Care positive Translation Experts : Professional and accurate Translation Volume: 6 pages Completed: Apr 2007 Languages:English to Spanish Four Special Education Documents Great to work with. Excellent communication.Education / Pedagogy positive Cesa 6 : Janet has came thru for me numerous times on short notice. I appreciate her accuracy. Translation Volume: 250 words Completed: Apr 2007 Languages:Spanish to English Police Document Law: Contract(s) positive Translation Experts : No comment. Translation Volume: 300 words Completed: Apr 2007 Languages:Spanish to English Birth Certificate Great company to work with.Certificates, Diplomas, Licenses, CVs positive Translation Experts : No comment. Editing/proofreading Volume: 1428 words Completed: Mar 2007 Languages:English Proofreading and editing of a website link Education / Pedagogy positive Iwith : No comment. Editing/proofreading Volume: 10 pages Completed: Mar 2007 Languages:English Ten page proofreading/editing of a document Computers (general) positive Iwith : No comment. Translation Volume: 1100 words Completed: Feb 2007 Languages:Spanish to English Translation of Website Page Education / Pedagogy positive Iwith : No comment. 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Translation Volume: 71 pages Completed: Oct 2006 Languages:English to Spanish translation of Special Education Documents. Wonderful agency to work with.Education / Pedagogy positive Unlisted : No comment. Interpreting Volume: 0 chars Duration: Feb 2007 to Dec 2007 Languages:English to Spanish Telephone Interpreting HCS is a wonderful company to work withFinance (general) No comment. Translation Volume: 2000 words Completed: Jun 2006 Languages:Spanish to English medical documents Medical: Health Care No comment.
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Sample translations submitted: 3 Spanish to English: Medical document sample Source text - Spanish Escribo en el seguimiento de Sra. Stuart que experimentó la cirugía de la catarata del ojo izquierdo en el 15 de enero de 2003, y fue visto en el 22 de enero de 2003, con 20/40 agudeza visual sin corregir en el ojo izquierdo. Su segmento anterior era fijo con un injerto de lente y cápsula central claro. Ella presiona eran 15 Mm y 17 Mm. Ella fue instruida para verle para un cambio de lente. Ella ha sido planificada para la cirugía correcta de la catarata de ojo en a mediados de febrero 2003.
Gracias otra vez para permitirme tomar la parte en esta administración de paciente.
Sinceramente,
John T. Smith, MD
Translation - English I am writing in follow-up of Ms. Stuart who underwent cataract surgery of the left eye on January 15, 2003, and was seen on January 22, 2003, with 20/40 uncorrected visual acuity in the left eye. Her anterior segment was stable with a clear central lens implant and capsule. Her pressures were 15 mm and 17mm. She was instructed to see you for a lens change. She has been scheduled for right eye cataract surgery in mid-February 2003.
Thank you again for allowing me to take part in this patient’s management.
Sincerely,
John T. Smith, MD
English to Spanish: Special Education Documents Detailed field: Education / PedagogySource text - English (If you need this notice in a different language or communicated in a different way, or have questions about this notice, please contact the school district at ________________________.)
Child Name:
Date of Birth:
District of Residence:
O Parent/Guardian 1 O Parent/Guardian 2
Dear ________________________________________________: Date _______________________________
On ________________________________________, the individualized education program (IEP) team met to determine if your child
has, or continues to have, a disability and need for special education.
The IEP team determined your child is not eligible for special education because:
Initial evaluation: your child does not have an impairment.
Initial evaluation: your child has an impairment, but does not have a need for special education, and, therefore, is not a child with a disability.
Reevaluation: your child no longer has an impairment. As a result, special education and related services will no longer be provided to your child as of ______________________________.
Reevaluation: your child continues to have an impairment, but no longer has a need for special education. As a result, special education and related services will no longer be provided to your child as of ___________________________.
Enclosed is a copy of the IEP Team Evaluation Report (Form A-6), which includes documentation regarding your child’s eligibility for special education.
Other options, if any, related to the above proposal which were considered and the reason(s) they were rejected including a description of any other factors relevant to the proposed action include: None.
You and your child have protection under the procedural safeguards (rights) of special education law. The school district must provide you with a copy of your procedural safeguards once a year. Previously you received a copy of your procedural safeguards rights in a brochure about Special Education Rights for Parents and Children. If you would like another copy of this brochure, please contact the school district at the telephone number below. In addition to the district staff, you may also contact the organizations listed on the Special Education Rights for Parents and Children brochure if you have questions about your rights.
________________________________________________________ __________________________________
(Name and Title of District Contact Person) (Phone)
Translation - Spanish (Si usted necesita este aviso en un idioma distinto o comunicado en una manera distinto, o tiene pregunta acerca de este aviso, contactan por favor el distrito de escuela en ________________________.)
El Nombre del niño:
La fecha del Nacimiento:
El distrito de Residencia:
El Padre/Guardián O 1 El Padre/Guardián O 2
Estimado(a) ________________________________________________: La fecha _______________________________
En ________________________________________, el programa individualizado de la educación (IEP) el equipo cumplió determinar si su niño tiene, o continúa tener, una incapacidad y la necesidad para la educación especial.
El equipo de IEP determinó a su niño no es elegible para la educación especial porque:
La evaluación inicial: su niño no tiene un deterioro.
La evaluación inicial: su niño tiene un deterioro, pero no tiene una necesidad para la educación especial, y, por lo tanto, no es un niño con una incapacidad.
La re-evaluación: su niño no tiene un deterioro nada mάs. Como resultado, la educación especial y los servicios relacionados no hace sea proporcionado a su niño nada más el ______________________________.
La re-evaluación: su niño continúa tener un deterioro, pero no tiene una necesidad para la educación especial nada mάs. Como resultado, la educación especial y los servicios relacionados no hacen sea proporcionado a su niño nada mάs el___________________________.
Adjuntado es una copia del Informe de Evaluación de Equipo de IEP (Forma A-6), que incluye documentación con respecto a su elegibilidad de niño para la educación especial.
Otras opciones, si cualquiera, relacionado al encima de propuesta que se consideraron y la razón (es) ellos fueron rechazados inclusive una descripción de cualquier otros factores apropiado a la acción propuesta incluye: Ninguno.
Usted y su niño tiene la protección bajo el procesal protege (los derechos) de la ley especial de la educación. El distrito de la escuela le debe proporcionar con una copia de su procesal protege una vez un año. Previamente usted recibió una copia de su procesal protege los derechos en un folleto publicitario acerca de Derechos Especiales de Educación para Padres y Niños. Si usted querría otra copia de este folleto publicitario, contacta por favor el distrito de escuela en el número de teléfono abajo. Además del personal del distrito, usted puede contactar también las organizaciones listaron en los Derechos Especiales de la Educación para el folleto publicitario de Padres y Niños si usted tiene pregunta acerca de sus derechos.
________________________________________________________ __________________________________
(El nombre y el Título de Persona de Contacto de Distrito) (Teléfono)
Spanish to English: 2011-A-089835-SA-LIT_Spanish General field: MedicalDetailed field: Medical: Health CareSource text - Spanish Cómo citar este artículo: Salas G, et al. Hidrocortisona para el tratamiento de hipotensión refractaria: ensayo clínico
controlado y aleatorizado. An Pediatr (Barc). 2013. http://dx.doi.org/10.1016/j.anpedi.2013.08.004
ARTICLE IN PRESS +Model
ANPEDI-1385; No. of Pages 7
An Pediatr (Barc). 2013;xxx(xx):xxx---xxx
www.elsevier.es/anpediatrORIGINALHidrocortisona para el tratamiento de hipotensión refractaria:ensayo clínico controlado y aleatorizadoG. Salasa, M. Travagliantib, A. Leoneb, C. Couceiroa, S. Rodríguezcy D. Fari˜naa,∗aÁrea de Terapia Intensiva Neonatal, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Ciudad Autónoma de Buenos Aires,ArgentinabÁrea de Farmacia, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Ciudad Autónoma de Buenos Aires, ArgentinacDocencia e Investigación, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Ciudad Autónoma de Buenos Aires, ArgentinaRecibido el 10 de enero de 2013; aceptado el 26 de agosto de 2013PALABRAS CLAVEHidrocortisona;Hipotensión;Inotrópicos;Dopamina;Epinefrina;EsteroidesResumenIntroducción: La hipotensión arterial es un signo frecuente en recién nacidos críticamenteenfermos. Varios estudios clínicos se˜nalan que series cortas de corticoides aumentan la PA y dis-minuyen el requerimiento de inotrópicos en prematuros con hipotensión. Existe escaso númerode estudios de empleo de hidrocortisona para el tratamiento de la hipotensión refractaria enrecién 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 ≥ 14 g/k/miny/o epinefrina. Dise˜no: prospectivo, controlado, aleatorizado, doble ciego con placebo.Intervención: HC: 2,5 mg/kg c/12 h, por 48 h por vía intravenosa (IV) (grupo intervención [GI]);placebo: solución fisiológica 1,25 ml/kg/dosis IV (grupo placebo [GP]). Se efectuó aleatorizaciónen bloques con asignación oculta.Resultados: Ingresaron al estudio 50 RNT con hipotensión refractaria. No se observaron dife-rencias significativas entre los 2 grupos. La reducción del soporte inotrópico a las 48h en el GIse alcanzó en el 60% de los pacientes vs. el 24% en el GP (p = 0,009, RR = 2,5, IC del 95%, 1,16a 5,38). Se observó una asociación significativa entre la administración de HC en RNT tratadoscon epinefrina y la presencia de hiperglucemia (p = 0,008).Conclusión: La administración de HC en pacientes con hipotensión refractaria redujo la nece-sidad de soporte inotrópico. Estos datos contribuyen a continuar investigando acerca del papelde los esteroides en el soporte hemodinámico de pacientes críticos.© 2013 Asociación Espa˜nola de Pediatría. Publicado por Elsevier España, S.L. Todos los derechosreservados.Presentado en 46.aReunión de la Sociedad Latinoamericana de Investigación Pediátrica 2008. Sociedad Iberoamericana de Neonatología.Cusco, Perú, septiembre del 2008.∗Autor para correspondencia.Correos electrónicos: [email protected] , [email protected] (D. Fari˜na).
1695-4033/$ – see front matter © 2013 Asociación Espa˜nola de Pediatría. Publicado por Elsevier España, S.L. Todos los derechos reservados.
http://dx.doi.org/10.1016/j.anpedi.2013.08.004 Translation - English +Model
ANPEDI-1385; No. of Pages 7 ARTICLE IN PRESS
An Pediatr (Barc). 2013;xxx(xx):xxx---xxx
www.elsevier.es/anpediatr
ORIGINAL
Hydrocortisone for the treatment of refractory hypotension: a randomized controlled trial.
G. Salasa, M. Travagliantib, A. Leoneb, C. Couceiroa, S. Rodríguezc y D. Farin˜aa,∗
a Neonatal Intensive Care Area, Pediatric Hospital, Prof. Dr. Juan P. Garrahan, Autonomous City of Buenos Aires,
Argentina.
b Pharmacy area, Pediatric Hospital, Prof. Dr. Juan P. Garrahan, Autonomous City ofBuenos Aires, Argentina.
c Teaching and Research Pediatric Hospital Prof. Dr. Juan P. Garrahan, Autonomous City of Buenos Aires, Argentina.
Received January 10, 2013; accepted on August 26, 2013
KEY WORDS
Hydrocortisone;
Hypotension;
Inotropics; Dopamine; Epinephrine; Steroids
Summary
Introduction: Arterial hypotention is a common sign in critically ill newborns. Several clinical studies have shown that a short series of corticosteroids increase the BP and decrease the need for inotropics in preterm infants with hypotension. There are a number of studies that use hydrocortisone for the treatment of refractory hypotension in newborns (RNT).The objective of this study is to evaluate the effectiveness of Hydrocortisone (HC) to reduce the inotropic support in RNT with arterial refractory hypotension.
Material and methods: All RNT were included with dopamine requirements of ≥ 14 IJg/k/min
and/or epinephrine. Design: prospective, controlled, randomized, double blind trial with placebo.
Intervention: HC: 2.5mg/kg c/12 hours, for 48 hours intravenously (IV) ( intervention group [IG]); placebo: isotonic saline 1.25ml/kg/dose IV (placebo group [GP]). Randomization was performed in blocks with concealed allocation.
Results: 50 RNT with refractory hypotension were entered in the study. No significant differences were observed between the 2 groups. The reduction in inotropic support in 48 hours in the IG was achieved in 60% of the patients vs. 24% in the GP (p = 0.009, RR = 2.5, 95% CI, 1.16 to 5.38). An association was observed between the significant administration of HC in RNT treated with epinephrine and the presence of hyperglycemia (p = 0.008).
Conclusion: The administration of HC in patients with refractory hypotension reduced the need for inotropic support. This data contributes to the continuing research in the role of steroids in the hemodynamic support of critically ill patients.
Spanish Association of Pediatrics © 2013 . Published by Elsevier España, S.L. All rights reserved.
Presented at the 46th Meeting of the Latin American Society of Pediatric Research 2008. Iberoamerican Society of Neonatology. Cusco, Peru. September 2008.
∗ Author of correspondence.
E-mails: [email protected] , [email protected] (D. Farin˜a).
1695-4033/$ – see front matter © 2013 Spanish Association of Pediatrics. Published by Elsevier España, S.L. All rights reserved.
http://dx.doi.org/10.1016/j.anpedi.2013.08.004
ANNALS OF PEDIATRICS
How this article was cited: G Salas, et al. Hydrocortisone for the treatment of refractory hypotension: randomized and
controlled clinical trial. Annal of Pediatrics (Barc). 2013. http://dx.doi.org/10.1016/j.anpedi.2013.08.004
+Model
ANPEDI-1385; No. of Pages 7 ARTICLE IN PRESS
2 G. Salas et al
KEYWORDS
Hydrocortisone; Hypotension; Inotropics; Dopamine; Epinephrine; Steroids
Hydrocortisone for the treatment of refractory hypotension: a randomized controlled trial
Abstract
Introduction: Systemic hypotension is a common sign in critically sick infants. Several studies have suggested that the use of a 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 inotro- pic support in infants with refractory hypotension. Population: infants who required dopamine
≥ 14 IJg/kg/min and/or epinephrine.
Design: prospective, controlled, randomized, double blind trial with placebo.
Intervention: HC: 2.5mg/kg every 12 hours, for 48 hours intravenously (intervention group [IG]); placebo: isotonic saline 1.25ml/kg/doses intravenously (placebo group [PG]) every 12 hours, for 48 hours. Randomization 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 48 hrs 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 hyperglycemia (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.
© 2013 Asociación Espan˜ola de Pediatría. Published by Elsevier España, S.L. All rights reserved.
Introduction
Arterial hypotension is a common sign of critically ill NB’s hospitalized in the Neonatal Intensive Care Unit (NICU). It is estimated that approximately half of the patients admitted to NICU will receive some treatment intended to raise your blood pressure (BP) in order to preserve blood flow to vital organs, such as the central nervous system, myocardium and kidney1,2.Current treatments for the treatment of hypotension are volume expanders and inotropes (dopamine, dobutamine, epinephrine, noreinephrine) 3,4. The majority of the NB’s with arterial hypotension respond to conventional treatment, however, there is a group of extremely ill NB’s (severe asphyxia, prolonged and complicated surgeries, septic shock, pulmonary hypertension)who have great hemodynamic instability with refractory hypotension to conventional treatment5. Refractory hypotension persistently dominates in them despite the therapeutic maximum (elevated doses of inotropic and expanders). It is postulated that this phenomenon is due to a gradual desensitization of the receptors in the cardiovascular system to the catecholmines (down-regulation) that involves the destruction of the same lysosomes. This down-regulation would occur after several hours of exposure to the receptors of high doses of endogenous or exogenous catecholmines6,7. On the other hand, in diferent clinical situations it has been published that absolute or relative adrenal insufficiency might contribute to this resistance in the effectiveness of vasoactive drugs. However, not all children with low levels of cortisol have refractory hypertension, and inversely, children within normal ranges of cortisol concentrations can develop a clinical picture with severe hemodynamic compromise 5.
The possibility of using corticosteroids for the treatment of refractory hypotension to conventional therapy has been investigated in adults8, in pediatric patients 9,10 and in premature NB’s11---13. Corticosteroids regulate the expression of adrenergic receptors and some members of the second messenger system (geonomic effects), stimulate the linking of the catecholmines on the cell surface, decrease the metabolism of catecholamines and increase the availability of intracellular calcium3,14,15. The Hospital of Pediatría Prof. Juan P. Garrahan is a third- level , without maternity, which belongs to the public health sector. The NB’s who are admitted to the neonatal intensive care are treated for conditions that couldn’t be resolved in the maternity ward. A high percentage of the children admitted to the intensive care are critically ill, with hemodynamic instability. If these symptoms are not reversed with conventional treatment, it is not uncommon to administer a short series of HC; however, the usefulness of this treatment has not been demonstrated.
The objective of this study is to establish that Hydrocortisone (HC) treatment compared to placebo reduces the need for inotropic support in preterm infants with arterial refractory hypotension to the treatment. Secondly, it evaluated the effect of HC on hemodynamic parameters, mortality, and the emergence of short-term adverse effects that were linked to its administration.
How this article was cited: G Salas, et al. Hydrocortisone for the treatment of refractory hypotension: randomized and
controlled clinical trial. Annal of Pediatrics (Barc). 2013. http://dx.doi.org/10.1016/j.anpedi.2013.08.004
+Model
ANPEDI-1385; No. of Pages 7 ARTICLE IN PRESS
Hydrocortisone in refractory hypotension: randomized and controlled study 3
Material and methods
- Population: A total of 50 FTI’s with refractory hypotension were prospectively recruited. Inclusion criteria were: Gestational age ≥ 37 weeks; systemic hypotension despite treatment with volume expanders (isotonic saline solution 10-20 ml/kg) and dopamine ≥14 IJg/kg/min for at least two hours. Each patient that complied with the eligibility criteria was admitted consecutively to the study after the informed consent was signed by their mother, father, or primary caregiver.
--- Exclusion criteria were: patients with major malformations or lethal chromosomal abnormalities, with congenital adrenal hyperplasia, with hypovolemic or hemorrhagic shock, with congenital heart disease, obstruction of the left ventricular outflow tract, or those who have received postnatal steroids.
--- Design: prospective study, double blind, randomized study, with controlled placebo use, developed in the Neonatal Intensive Care Unit in the Prof. Dr. J.P. Pediatric Hospital, Buenos Aires, Argentina.
--- Randomization: a randomized mechanism was used in four simple blocks generated by using random numbers. The number sequence was hidden in opaque envelopes, in the hospital pharmacy, and was not available to the rest of the reviewers.
--- Implementation: 2 drugs (MT, ML) were used for defining allocation and preparation of the product (Placebo or HC). These were the only known contents in each syringe; they were pre-filled, numbered, and ready to be used in the NICU. To ensure blinding of the study, both drugs(HC or placebo)were the same color, odorless, diluted in the same measured volume, and equivalent to a dose of 2.5mg/kg of HC. Each patient received a treatment course of 2 days with HC sodium succinate 2.5mg/kg per dose intravenously every 12 hours or isotonic saline as placebo.
---- Primary effect measure: the intervention was considered effective if the decrease in inotropic support was achieved within 48 hours of initiating the study; this decline was defined as a decrease in the dose of dopamine by 50% of initial value and/or suspending the administration of epinephrine.
--- Elimination criteria: blood glucose greater than 300 mg %, despite decreasing the glucose flow to 4mg/kg/min or gastrointestinal bleeding (hematemesis or melena). In these cases, treatment was suspended; the data was incorporated in the final intent- to - treat analysis.
--- Hypotension treatment: hypotension was defined as an average BP lower than the 5th percentile for 5 hours/days of life and weight16. In accordance with the consensus of treatment in our Unit, the sequence of treatment in patients born at term with systemic hypotension is the following: initially use 2 bags of saline solution 10ml/kg/dose in expansion mode; if the 2 volume expansions are not sufficient, 5-10 IJg/kg/min of dopamine is added, and increased gradually until achieving a desired BP. The use of dobutamine is reserved in those patients with contractile dysfunction.
If you don’t achieve the expected effect with these
inotropes, 0.1 IJg/kg/min. of epinephrine is indicated. This is not used for routine blood products, such as red blood cells or fresh frozen plasma or platelets, unless the patient has anemia, coagulation disorders or thrombocytopenia.
--- For puposes of the study, it was considered refractory hypotension after 2 hours of treatment (2 volume expansions and dopamine ≥ 14 IJg/kg/min and/or starting epinephrine),and the BP continued at values below normal.
- Mortality: The mortality analysis was completed within 15 days of each patient’s admission.
The study was open; the neonatologist was in charge of the patient, blindly assigned, and could administer corticosteroids when needed outside the protocol if he/she considered it necessary following in his/ her clinical judgement, in all cases, said treatment was recoreded as a co-intervention.
The study variables collected were: gestational age, birth weight and follow-up hospital protocol for each patient. Systolic, diasystolic and mean BP’S were taken(by invasive or non-invasive methods) immediately before treatment at 2, 6, 12, 24, and 48 hours; in addition, we checked the heart rate, urinary flow, intravenous fluid use, dose and type of inotropes used, blood glucose values, and other therapeutic co interventions in the same intervals; systematically recorded gastrointestinal bleeding occurrences, signs of infection and/or confirmed sepsis, and this was generally done within the first 15 days of the initial patient inclusion protocol.
This study was approved by the Institutional Review Board and by the Garrahan Hospital Ethics Committee (Registry Number: 729/04), and by the ANMAT(Administración Nacional de Medicamentos, Alimentos Y Technología Médica)(National Administration of Drugs, Foods, and Medical Devices)] regulatory body in Argentina. Under the independent investigator category (Disp. Number 1674. File number 1-0047-0000-01284-02-5).
- Statistical analysis: Descriptive statistics are expressed as either mean or average « standard deviation or interquartile range, and percentage. They used the Student or Mann Whitney U test for continuous variables and the chi-square test for continuous categorical [variables]. Kaplan Meier curves were made to estimate the effect of the treatment on the decline of vasopressors during the follow-up period of the study; the comparative analysis was done by using the log-rank test. The results are shown as relative risk, the number needed to treat, and 95% confidence interval [CI]. STATA 9.0 for Windows was used as a statistical package (Statacorp, Texas, USA). A significance level of 5% was established for all comparisons. The results of all the patients included in the study were analyzed according to the intent to treatment.
To calculate the sample size, previous data from the unit was used, which showed a favorable baseline response rate of 10%. The need to recruit 21 patients was calculated in each arm to demonstrate a relevant difference in the effect (estimated as an increase from 10 to 60% of the response shown after treatment with corticosteroids).
How this article was cited: G Salas, et al. Hydrocortisone for the treatment of refractory hypotension: randomized and
controlled clinical trial. Annal of Pediatrics (Barc). 2013. http://dx.doi.org/10.1016/j.anpedi.2013.08.004
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ANPEDI-1385; No. of Pages 7 ARTICLE IN PRESS
4 G. Salas et al
Evaluated eligible (n=51)
Excl Pad parti
Randomized (n = 50)
% Patients
Recruitment
Allocation
luded (n = 1)
1,00
0,75
0,50
0,25
Kaplan-Meier survival estimates, by cort
GP
IG
Assigned to intervention (IG) (n = 25)
♦Received hydrocortisone (n = 31)
Assigned to placebo (GP) (n = 25)
♦Only received placebo (n = 18)
0,00
0 10 20
30 40 50
Losses in follow-up (n = 0) Discontinued intervention (n = 0)
Analized (n = 25) Without exclusions
Follow-up
Analysis
Losses in the follow-up (n = 0) Discontinued intervention (n = 0)
Analized (n = 25) Without exclusions
Analysis time
Cort = 0 Cort = 1
Minutes elapsed until the decline of inotropic support.
Figure 2 Comparative Kaplan Meier curves between IG (cort = 1) vs. PG (cort = 0).
IG:intervention group; GP: placebo group.
Figure 1 Flow diagram.
with 90% power (error = 0.10) and a 0.05 error (2 tailed).
Results
A total of 51 children with eligible criteria, 50 were enrolled in the protocol. Only 1 patient was excluded due to lack of family consent. Twenty five patients were randomized to the intervention group (IG) and 25 patients to the placebo group (PG); Thirty one children received HC and 19 received placebo, since it was an open-label study, where the attending physician could introduce corticosteroids if it was considered necessary. The 6 patients who received steroids belonged to the placebo group. In figure 1 the flow chart shows the study subjects in all stages in accordance with the recommendations from the CONSORT Group17. The IG and PG groups were similar at the beginning of the study (table 1). The main causes for hospitalization of patients enrolled in the study were: pulmonary hypertension (n = 23), congenital heart disease (n = 18) and surgical conditions (n = 9). In the NB’s with pulmonary hypertension, 11 were patients with congenital diaphragmatic hernias, 4 with meconium aspiration syndrome, 4 with primary pulmonary hypertension,
3 with pneumonia, and one with cystic adenomatoid malformation. The reason for the treatment of HC was refractory hypotension, due to septic shock in 34% of the cases. The decline in the inotropic support during the follow-up period occurred in 21 of the 50 patients that were admitted to the study, 15 patients (60%) belonged to the IG and 6 patients(24%) to the GP. This difference was statistically significant, p = 0.009; RR 2.5 (95% CI, 1.16-5.38). The number needed to treat on the basis of this difference is 2.77. In addition, we explored whether the decline in inotropic support was different during the course of the study, whereby we measured in time (hours) in which each patient reached the event in question(lower inotropic support). Figure 2 notes that there are differences in the two survival curves in favor of the treated group, in which the expected response occurs significantly earlier (log-rank test 0.02). No significant statistical differences were found in the rest of the hemodynamic variables studied: heart rate, BP or urinary flow at 2, 6 12, 24 and 48 hours after treatment. Figure 3 represents BP values from both groups in the intervals of 0,12,24, and 48 hours after treatment. Eighty four % of patients (42/50) required the use of additional volume expansion during the study; the requirement of frequent expansions (> 2) was
Table 1 Characteristics of the populations treated with hydrocortisone or with placebo at the beginning of the study
Hydrocortisone (25)
Placebo (25)
p
Days of lifea
7 (2-20)
6 (3-19)
0.80
Weight (g), average± SD
2.936± 680
3.184± 805
0.24
Males, n (%)SD
11 (44%)
12 (48%)
0.77
EG (s), average±
Dopamine doses (IJg/kg/min)a
38± 1,4
18 (14-20)
38± 1.8
17 (9-18)
0.67
0.39
Epinephrine dose (IJg/k/min)a
0.5 (0.5-0.7)
1 (0.3-1)
0.80
Urinary flow (ml/kg/h)a
2.55 (1.3-3.6)
2.6 (1-3)
0.65
Infusion volume (ml/kg)a
60 (40-70)
60 (60-80)
0.33
Mean arterial pressure (mmHg)a
46 (38-58)
46 (39-50)
0.63
Heart rate(cycles/min)a
168 (150-180)
153 (143-167)
0.08
From standard deviation; GE: gestacional age.
a The results are expressed as an average (interquartile range).
Excluded (n = 1)
Parents did not accept in participation ( n = 1)
How this article was cited: G Salas, et al. Hydrocortisone for the treatment of refractory hypotension: randomized and
controlled clinical trial. Annal of Pediatrics (Barc). 2013. http://dx.doi.org/10.1016/j.anpedi.2013.08.004
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ANPEDI-1385; No. of Pages 7 ARTICLE IN PRESS
Hydrocortisone in refractory hypotension: randomized and controlled study 5
Corticosteroid
Placebo
p
Hyperglycemia
9 (36%)
6 (24%)
0.35
Hypertension arterial
2 (8%)
0
0,14
Hemorrhagic digestive
3 (12%)
2 (8%)
0,63
Sepsis
0
2 (8%)
0,14
0 1
100
80
60
40
20
GP = 0 and IG = 1
TAM = average blood pressure
TAM 0
TAM 12
TAM 24 TAM 48
Figure 3 Blood pressure at 0, 12, 24 and 48 hours in both groups.
more frequent in the placebo group (32%) vs. the intervention (24%), although the difference was not statistically different. Table 2 shows adverse effects in both groups; there were no significant differences in complications present that attributed to HC treatment. Hyperglycemia was more frequent in patients who received epinephrine (14/28, 50%); in contrast, among the patients who did not receive this drug, only one had hyperglycemia. This difference was significant and showed the association between hyperglycemia and the use of epinephrine. (p = 0.008). No differences were observed between the groups in other possible adverse effects (table 2). Ten out of the 50 patients (20%) died; 3 of them belonged to the IG (12%) and 7 to the PG (28%) (p = 0.15, RR 0.42, 95% CI, 0.12-1.42); Despite the fact that this evolution difference in our sample seems significant, the study was not designed to show the effect on mortality and, therefore, has not had enough statistical power to infer that the use of corticosteroids may be related to the considerable decrease in this group of children with high threat to life due to their initial initial condition.
Discussion
The use of corticosteroids in order to support hemodynamic management of children has been proposed in numerous studies. Although the results are not conclusive, some authors would recommend their use in those patients with refractory hypotension to treatment with volume and vasopressors 18.
Table 2 Incidence of adverse effects in both groups
There are a greater number of studies in the neonatal preterm period19---23 than in the FTI’s (5, 15). In a recent randomized, controlled and blind study, Ng et al evaluated the effectiveness of a stress dose of HC (1mg/kg every 8 h for 5 days) vs. placebo for the rescue treatment in very low birth weight premature infants with refractory hypotension and adrenal insufficiency. The result showed that 79% of patients treated with HC vs. 33% of the placebo group achieved suspension of inotropic support within 72 hours after starting the treatment19.
In pediatric patients with hypotension caused by infection or in recovery after cardiovascular surgery,several studies have developed that show a hemodynamic improvement after steroid treatment23---25. In clinical guidelines developed by the American College of Critical Care Medicine for neonates and children with septic shock, the committee maintains that the «equipoise» in terms of to adjunctive treatment with corticosteroids in the treatment of sepsis in the pediatric age group, with exception of adrenal or hypothalamus-pituitary axis insufficiency. These guides aim to add HC treatment of neonates that are in risk of adrenal insufficiency defined as a peak cortisol value after stimulation with adrenocorticotropic < 18 mg/dl or a baseline value of < 18 mg/dl after adequate expansion and epinephrine10.
With respect to the experience published in the FTI’s, Baker et al., reported a retrospective study of 117 RN with refractory hypotension (61 patients with the birth weight > 2.500 g) treated with a standardized protocol of HC. In spite of the fact that this study was heterogenous, the administration of HC was uniformly associated with the rise in BP, a decrease in the inotrope dosage, and increase in urine output. These results were independent of the gestational age, birth weight, and the baseline cortisol value before the start of treatment26.
26 .
In 1999, Tantivit et al. reported their experience in 7 FTI’s with refractory hypotension that were treated with dexamethasone. In all of the NB’s, we observed a decrease
Table 2 Incidence of adverse effects in both groups
Corticosteroids Placebo P
Hyperglycemia 9 (36%) 6 (24%) 0.35
Blood Pressure 2 (8%) 0 0.14
Mild gastrointestinal bleeding 3(12%) 2 (8%) 0.63
Sepsis 0 2 (8%) 0.14
How this article was cited: G Salas, et al. Hydrocortisone for the treatment of refractory hypotension: randomized and
controlled clinical trial. Annal of Pediatrics (Barc). 2013. http://dx.doi.org/10.1016/j.anpedi.2013.08.004
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ANPEDI-1385; No. of Pages 7 ARTICLE IN PRESS
6 G. Salas et al
Requirement of the inotropes, the need for expansions, and increased urine output27.
Noori et al., is an observational, prospective study that evaluated whether the administration of HC was associated with hemodynamic changes in NB’s receiving high doses of dopamine. The results showed that at 48 hours of treatment with HC, the dopamine dosage decreased by 72% and BP and systolic volume raised 31 and 33%, respectively28.
Kamath et al. evaluated the presence of adrenal inadequacy in 34 FTI’s with congenital diaphragmatic hernias. They noted that 67% of the patients had low levels of plasmatic cortisol (< 15 IJg/dl) and that this situation was associated with greater severity of the disease. In this report, 100% of the patients with low levels of cortisol and 69% of patients with high levels of cortisol received corticosteroids as part of their treatment29.
As we can observe, the studies on th FTI’s are retrospective or based on the number of patients. Our study, despite being prospective, controlled, and with a greater number of patients, suffers from some weaknesses. The studied population constitutes a group of children coming from maternity hospitals with serious diseases, where the transfer impact adds morbidity to the underlying disease30. Overall mortality in the NICU is around 5%; however, this group of patients belongs to the most critical, which would explain their high mortality. In our study, measurement of results was based on the clinical judgement of the neonatologist, which considers the BP value, associated with the evaluation of patient infusion (urinary output, capillary fill, and tempurature in the extremities), to make decisions about inotrope management. Lastly, our study did not document adrenal insufficiency through the dosage of plasmatic cortisol to establish the role of adrenal insufficiency in this population.
Finally, while this study has not been observed as a significant difference in the occurrence of short term adverse effects, it still not been evaluated on the long-term impact in this intervention, especially in relation to the neurological development of these children. All of these patients are in follow-up. This study showed that treatment with HC decreased inotropic requirements in the studied population. Based on this information, we deem it reasonable to use low doses of HC in FTI’s that remain hypotensive despite high doses of vasopressors. The optimal daily dose, the duration of treatment, and the need for routine plasmatic cortisol values are still issues that would need to be determined. While the use of corticosteroids cannot yet be recommended in medical practice for the management of hypotension in these patients, it is possible that administration could be considered in refractory cases, when the clinic carefully considers each case and the unit agrees on a standardized protocol that allows for assessment of short and long-term results.
Conflict of interest
The authors declare that they have no conflicts of interest.
Acknowledgements
To all the medical team and Nursing staff from the Neonatology Service of the Hospital of Pediatría Prof Juan P. Garrahan, thanks for their unconditional support which made this study possible.
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How this article was cited: G Salas, et al. Hydrocortisone for the treatment of refractory hypotension: randomized and
controlled clinical trial. Annal of Pediatrics (Barc). 2013. http://dx.doi.org/10.1016/j.anpedi.2013.08.004
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