[Prevalence of hypophosphatemia in children with diabetic ketoacidosis and treatment with subcutaneous regular insulin. Observational study]. / Prevalencia de Hipofosfatemia en niños con cetoacidosis diabética y tratamiento con insulina regular subcutánea. Estudio observacional.

Diabetic ketoacidosis (DKA) is one of the most serious complications of type 1 diabetes mellitus. Its treatment requires fluid and electrolyte replacement and insulin. Hypophosphatemia as a complication of treatment has been scarcely evaluated. OBJECTIVES: To estimate the incidence of hypophosphatemia in children with DKA, treated with subcutaneous regular insulin (IRS), and to explore factors associated with this complication. PATIENTS AND METHOD: Prospective, observational study. Patients diagnosed with DKA hospitalized in the general care ward were included. Data on phosphatemia, glycemia, acid-base status, and IRS amount (U/kg) received were recorded at baseline and after 24 h of treatment. Hypophosphatemia was defined as values below 2.5 mg/dl. The correlation between initial phosphate and at 24 h of treatment was evaluated; the incidence of hypophosphatemia at 24 h was expressed as a percentage of the total number of patients. RESULTS: 30 patients were included, 15 were female, mean age 11.4 ± 3.2 years. At 24 h of treatment with IRS, 36.7% (95%CI 22-55%) presented hypophosphatemia, mean value 1.9 ± 1.5 mg/dl. Initial bicarbonate < 10 mmol/L acted as a predictor of hypophosphatemia (OR 7.5; 95%CI 1.4-39.8%; p = 0.01). No patient required intravenous phosphate correction, and no associated clinical complications were observed. CONCLUSION: In the group studied, the incidence of hypophosphatemia reached 36.7% at 24 hours of treatment. Initial bicarbonate lower than 10 mmol/L was significantly associated with hypophosphatemia. No complications associated with hypophosphatemia were observed.

Ética en investigación: desafíos durante la pandemia / Research ethics: challenges during the pandemic

Durante la pandemia de Covid-19 los hospitales pediatricos se vieron menos afectados, debido a la menor infección en niños, y sus recursos fueron reasignados en distintas tareas.. El Comité de Ética en Investigación del Hospital General de Niños Pedro de Elizalde presenta los distintos procedimientos implementados en esta emergencia, para sostener diferentes investigaciones, y que les permitió una rápida respuesta a esta situación.

Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis: A Feasibility Controlled Clinical Trial.

BACKGROUND: Although intravenous insulin administration is the standard of care in diabetic ketoacidosis (DKA), subcutaneous insulin administration could be a suitable alternative in resource-limited settings, but pain caused by hourly insulin applications are limiting factors for using it, especially in children. We aimed to assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared with the usual hourly injections' treatment. We also compared the evolution of metabolic variables in patients with DKA using both insulin administration systems. METHODS: Randomized feasibility controlled open trial, comparing 2 ways (flexible catheter and steel needle) for the initial insulin administration in children with DKA, who were randomly selected to receive subcutaneous insulin by a flexible catheter or using standard needles. The main outcome was pain, assessed hourly and secondary outcome time to achieve ketoacidosis resolution. RESULTS: Twenty subjects were included (10 by group). There were no differences between groups in baseline lab values (glycemia, urea, sodium, bicarbonate and pH). Pain assessment at first insulin administration was significantly lower in the intervention group (4.5 vs 0 points; P = 0.001). Similar differences between both treatment arms were observed in every pain assessment. There were no differences between groups regarding the time elapsed to achieve ketoacidosis resolution. (11.4±4.3 vs 16±8.4; P = 0.12). No adverse events or DKA complications were observed. CONCLUSIONS: The use of a flexible catheter reduced the pain associated with subcutaneous insulin administration in nonsevere DKA. The flexible subcutaneous catheter could be a safe alternative for the treatment of uncomplicated DKA in resource-limited settings.

The Influence of Chloride for the Interpretation of Plasma Bicarbonate During the Treatment of Diabetic Ketoacidosis.

INTRODUCTION: Hyperchloremic metabolic acidosis can occur in diabetic ketoacidosis (DKA) and may affect the acid-base interpretation during treatment. OBJECTIVES: This study aims to describe the prevalence of hyperchloremia during the treatment of DKA and its effect on the interpretation of bicarbonate value. METHODS: A cross-sectional study, including all cases of DKA in patients aged 1 to 18 years old admitted from 2010 to 2015, was performed. Laboratory tests were performed on admission (baseline), 2 and 6 hours after admission, and when resolution of DKA was achieved. Adjusted bicarbonate value was calculated using regression equations. RESULTS: Seventy-nine DKA episodes were included. The average age was 13.3 ± 3.8 years. Baseline levels were as follows: plasma glucose, 479 ± 133 mg/dL; pH 7.1 ± 0.083; bicarbonate, 9.65 ± 2.9; and anion gap, 23.9 ± 7.5. The time to achieve resolution of DKA was 12.2 ± 4.4 hours, and the decrease in capillary glucose was 25.5 (19.7-38.2) mg/dL per hour. After 6 hours of treatment, the proportion of patients presenting hyperchloremia increased from 23% to 77%. By using adjusted bicarbonate, the percentage of patients achieving resolution of DKA after 6 hours of treatment would have been 35.4% (confidence interval 95%, 28-49), in comparison with 24.1% (confidence interval 95%, 18-37) using observed bicarbonate (P = 0.004). CONCLUSIONS: The hyperchloremia developed during the treatment of DKA could modify the value of measured plasma bicarbonate concentration and unnecessarily prolong the initial phase of treatment.

Medicamentos fuera de prospecto en Pediatría / Off-label drugs in Pediatrics

INTRODUCCIÓN El término "off label" se refiere al uso de un medicamento que no está incluido en el prospecto (MFP), como es el caso de su posología, indicación, dosis, rango de edad y vía de administración. OBJETIVOS Estimar la prevalencia de prescripción de MFP en niños hospitalizados en unidad de cuidados generales y la prevalencia de EAM en este grupo. Evaluar si los pacientes con MFP presentan mayor riesgo de EAM comparado con los autorizados. MATERIALES Estudio transversal. Se incluyo una muestra aleatorizada de historias clínicas de pacientes de 1 mes y 18 años hospitalizados durante el año 2017. Dos especialistas en pediatría evaluaron en forma sistemática y estandarizada todas las historias seleccionadas en busca disparadores asociados a EAM, y de EAM y de prescripción de MFP. EAM, se expresó mediante proporción sobre el número total de prescripciones y sobre el número total de pacientes, para ambos grupos con y sin MFP. La MFP se expresó en proporción sobre el número total de prescripciones y sobre el número total de pacientes. RESULTADOS Se incluyeron 412 historias clínicas, 225 varones (54,9%), el promedio de edad de 2,2 años. Se registraron 1353 prescripciones, de la cuales 286 fueron MFP 21% y la prevalencia de uso de MFP sobre el total de sujetos fue de 56%. Dentro del número total de MFP la causa más frecuente fue la edad 58%, seguido por dosis administrada 35%, por vía de administración 4%, 4 sujetos (2%) recibieron MFP sin indicación médica y finalmente 3 sujetos (1%) por preparados farmaceuticos. Utilizando la herramienta de detección de EAM se detectaron 22 disparadores. De estos solo se observaron 5 efectos adversos. La prevalencia de EAM fue menor al 2%. DISCUSIÓN La prevalencia de uso de MFP sobre el total de sujetos fue de 56%, la prevalencia de EAM fue menor al 2%. Se requieren otros estudios para evaluar si los MFP presenta mayor riesgo de EAM comparado con los autorizados

Aplicación del Examen Clínico Objetivo Estructurado en la residencia de Pediatría de la Ciudad de Buenos Aires / The Use of the Objective Structured Clinical Examination for Paediatric residents in the City of Buenos Aires

Introducción: A pesar de considerarse el estándar de oro para la evaluación de competencias en posgrado, el Examen Clínico Objetivo Estructurado (ECOE) es escasamente aplicado en América Latina. El Gobierno de la Ciudad de Buenos Aires (GCBA) posee un sistema de residencia de Pediatría con cerca de 400 residentes, distribuidos en 13 hospitales, que comparten examen de ingreso y programa de formación. Nuestro objetivo es describir la experiencia de aplicación del ECOE a todos los residentes de Pediatría del GCBA, y comparar el desempeño según el tipo de hospital. Sujetos y método: Estudio descriptivo, incluyendo a todos los residentes de Pediatría del GCBA que finalizaban primer año, pertenecientes a 13 hospitales (2 pediátricos y 11 generales). El ECOE incluyó 10 estaciones. Resultados: Participaron 85 residentes; el 88,2% (IC 95% 79,7-93,5) aprobó la evaluación. No se encontraron diferencias significativas en la proporción de residentes que aprobó la evaluación entre los que provenían de hospitales pediátricos y los de hospitales generales (89,5 vs. 85,7%; OR = 1,4; IC 95% 0,4-5,5; p = 0,8). Conclusiones: En 2015 por primera vez se desarrolló un ECOE como evaluación unificada para todos los residentes de Pediatría del GCBA. La experiencia permitió identificar debilidades de cada evaluado y del sistema, estableciendo estrategias para superarlas.

Introduction: The Objective Structured Clinical Examination (OSCE) is considered the reference standard for competence evaluation, but its use in Latin America is limited. The City of Buenos Aires Government (CBAG) administers a Paediatric residency system that includes 400 residents distributed in 13 hospitals, sharing an admission system and education program. We aim to describe the experience of administering an OSCE for evaluating all the Paediatric residents of the CBAG. Subjects and method: Descriptive study, including all paediatric residents of the CBAG, belonging to 13 hospitals (2 paediatric and 11 general), ending their first year of training. The OSCE included 10 stations. Results: Eighty-five residents participated in the OSCE, and 88.2% (95% CI 79.7-93.5) passed the examination. There were no significant differences in the pass rate between residents from paediatric hospitals and from general hospitals (89.5 vs. 85.7%; OR = 1.4; 95% CI 0.4-5.5; P = .8). Conclusions: In 2015, the OSCE was administered to all paediatric residents of the CBAG for the first time. This experience allowed identifying weaknesses in the education system, in order to develop strategies to overcome them.

[Correlation between results of the residency admission test and of pediatric certification test in Buenos Aires, Argentina]. / Relación entre el desempeño en el examen de ingreso a la residencia y en el de especialización en pediatría en la Ciudad de Buenos Aires.

In the city of Buenos Aires (CABA), pediatric residents enter the residency program after taking a unified admission test. After completion of the program and passing a final test, the Universidad de Buenos Aires (UBA) provides a professional certification. The objective of this study is to determine if the results obtained in the residency admission test (RAT) and those of the professional certification test (PCT) correlated. This is a cross-sectional study, that included all subjects who passed the pediatrics RAT in CABA in 2004-2009, and that attended the pediatric PCT of the UBA. The score for each subject in both tests was obtained and the corresponding correlation was calculated. Results were divided in quintiles, and the proportion of subjects who improved their position in the PCT with respect to the RAT was calculated. Data from 303 subjects was obtained. The RAT showed a median of 45.0 (over 60 maximum) (IC-range: 43.0-48.7), and the PCT showed a median of 6 points (over 10 max.)(IC-range: 6-8). A significative correlation between results in RAT and PCT was observed (r = 0.37, p < 0.001). Based on their position in the RAT, 43.8% of subjects improved their position in the PCT, without differences between residents attending pediatric and general hospitals (45.6 vs. 31.5%; p = 0.1). In the case of pediatric residents, results of the residency admission test correlate with those obtained in the professional certification test.

Relación entre el desempeño en el examen de ingreso a la residencia y en el de especialización en pediatría en la ciudad de Buenos Aires / Correlation between results of the residency admission test and of pediatric certification test in Buenos Aires, Argentina

En la Ciudad de Buenos Aires (CABA) los ingresantes al sistema de residencia en pediatría lo hacen mediante un examen unificado y, al finalizar, rinden su examen de especialización en la Universidad de Buenos Aires (UBA). Existe evidencia de que el desempeño en determinadas evaluaciones podría predecir el rendimiento posterior. El objetivo de este estudio es evaluar si existe relación entre el examen de ingreso a la residencia (EIR) y el de especialización (EE) en pediatría. Se trata de una investigación transversal que incluye todos los sujetos que aprobaron el EIR de pediatría en CABA en 2004-2009 y que rindieron EE de pediatría en la UBA. Se obtuvo el puntaje de cada sujeto en ambos exámenes y se calculó la correlación correspondiente. Las notas fueron divididas en quintiles, calculando la proporción de alumnos que mejoró su ubicación en el segundo examen con respecto al primero. Se obtuvieron datos de 303 participantes. El examen de ingreso (calificación máxima de 60 puntos) mostró una mediana de 45.0 puntos (IIC: 43.0-48.7) y el examen de especialización (calificación máxima de 10 puntos) mostró una mediana de 6 puntos (IIC: 6-8), verificándose una correlación significativa entre la calificación del EIR y la del EE (r = 0.37, p < 0.001). En relación al quintil de referencia, 43.8% de los alumnos mejoró su ubicación en el EE respecto de la obtenida en el EIR, sin que se registraran diferencias entre residentes de hospitales pediátricos y de hospitales generales (45.6 vs. 31.5%; p = 0.1).

In the city of Buenos Aires (CABA), pediatric residents enter the residency program after taking a unified admission test. After completion of the program and passing a final test, the Universidad de Buenos Aires (UBA) provides a professional certification. The objective of this study is to determine if the results obtained in the residency admission test (RAT) and those of the professional certification test (PCT) correlated. This is a cross-sectional study, that included all subjects who passed the pediatrics RAT in CABA in 2004-2009, and that attended the pediatric PCT of the UBA. The score for each subject in both tests was obtained and the corresponding correlation was calculated. Results were divided in quintiles, and the proportion of subjects who improved their position in the PCT with respect to the RAT was calculated. Data from 303 subjects was obtained. The RAT showed a median of 45.0 (over 60 maximum) (IC-range: 43.0-48.7), and the PCT showed a median of 6 points (over 10 max.)(IC-range: 6-8). A significative correlation between results in RAT and PCT was observed (r = 0.37, p < 0.001). Based on their position in the RAT, 43.8% of subjects improved their position in the PCT, without differences between residents attending pediatric and general hospitals (45.6 vs. 31.5%; p = 0.1). In the case of pediatric residents, results of the residency admission test correlate with those obtained in the professional certification test.

[The Use of the Objective Structured Clinical Examination for Paediatric residents in the City of Buenos Aires]. / Aplicación del Examen Clínico Objetivo Estructurado en la residencia de Pediatría de la Ciudad de Buenos Aires.

INTRODUCTION: The Objective Structured Clinical Examination (OSCE) is considered the reference standard for competence evaluation, but its use in Latin America is limited. The City of Buenos Aires Government (CBAG) administers a Paediatric residency system that includes 400 residents distributed in 13 hospitals, sharing an admission system and education program. We aim to describe the experience of administering an OSCE for evaluating all the Paediatric residents of the CBAG. SUBJECTS AND METHOD: Descriptive study, including all paediatric residents of the CBAG, belonging to 13 hospitals (2 paediatric and 11 general), ending their first year of training. The OSCE included 10 stations. RESULTS: Eighty-five residents participated in the OSCE, and 88.2% (95% CI 79.7-93.5) passed the examination. There were no significant differences in the pass rate between residents from paediatric hospitals and from general hospitals (89.5 vs. 85.7%; OR=1.4; 95% CI 0.4-5.5; P=.8). CONCLUSIONS: In 2015, the OSCE was administered to all paediatric residents of the CBAG for the first time. This experience allowed identifying weaknesses in the education system, in order to develop strategies to overcome them.

[A comparison of two systems for hydration of children with diabetic ketoacidosis. a randomized controlled trial]. / Comparación de dos sistemas de aporte de soluciones hidroelectrolíticas para el manejo de la cetoacidosis diabética: ensayo clínico controlado y aleatorizado en niños.

BACKGROUND: Treatment of diabetic ketoacidosis (DKA) requires hourly controls of blood glucose, which define changes in the intravenous glucose and insulin administration. Every change requires preparing a new solution, wasting time and allowing errors. The two bag system (same electrolytes composition, but one with and the other without glucose) allows immediate changes in glucose administration rate, just by changing the solutions drip. OBJECTIVE: To compare the time needed to reach stabilization of patients with DKA using two different hydration systems: the traditional one (1 glucose/electrolyte solution) vs. the alternative one (2 glucose/electrolyte solutions -"two bag system"-). METHODS: Randomized controlled trial, including children aged 1 to 18 years, hospitalized for DKA (glycemia >200 mg/dl, pH <7.3, bicarbonate <15 mmol/L, glycosuria and ketonuria). After initial emergency re-hydration, patients were randomized to one of the 2 hydration systems (traditional or alternative), using it until patient stabilization (glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L); the time required to reach stabilization was the outcome variable. RESULTS: After enrolling 12 of the 32 planned subjects (6 in each group) Data Monitoring Committee performed a scheduled interim analysis, finding that the time required to reach stabilization was significantly shorter using the alternative system (9.8±1.16 hs vs. 13.3±2.8 hs; p=0.018). Because of the magnitude of this finding, the Ethics Committee decided to terminate the study.

Introducción: El tratamiento de la cetoacidosis diabética (CAD) requiere controles horarios de glucemia que definen modificaciones en la administración de insulina y glucosa endovenosa. En cada cambio se prepara una nueva solución endovenosa, generando retrasos y, eventualmente, errores. El sistema de dos soluciones hidroelectrolíticas (idéntica composición electrolítica, una con glucosa y otra sin) en paralelo unidas en una vía común al paciente, permite cambios inmediatos en el flujo de glucosa, con la sola modificación de los goteos. Objetivo: Comparar el tiempo requerido para la estabilización de pacientes con CAD, utilizando dos sistemas de hidratación: tradicional (1 solución hidroelectrolítica) vs. alternativo (2 soluciones hidroelectrolíticas ­"two bags"-). Métodos: Ensayo clínico controlado y aleatorizado que incluyó niños de 1 a 18 años, hospitalizados por CAD (glucemia >200 mg/dl, pH <7,3, bicarbonato <15 mmol/L, glucosuria y cetonuria). Luego de la hidratación inicial, los pacientes fueron aleatorizados a uno de 2 sistemas de hidratación (tradicional o alternativo), manteniéndolo hasta la estabilización del paciente (glucemia ≤250 mg/dl, pH ≥7,3, bicarbonato ≥15 mmol/L); el tiempo requerido en alcanzar la estabilización fue la variable de resultado. Resultados: Al incorporar 12 de los 32 sujetos previstos (6 en cada grupo¬) el Comité de Monitoreo de Seguridad efectuó análisis interino preestablecido, encontrando que el tiempo en alcanzar la estabilización fue significativamente menor con el sistema alternativo (9,8±1,16 horas vs. 13,3±2,8 horas; p=0,018). Debido a la magnitud del hallazgo, se consultó al Comité de Ética, decidiendo suspender el estudio. Conclusión: El sistema alternativo ("two-bags") permitió alcanzar la estabilización del paciente con CAD en un tiempo significativamente menor.