| Título : |
Adrenaline for the early resuscitation of children with sepsis - a randomizedcontrolled pilot study (ANDES CHILD): study protocol and analysis plan |
| Tipo de documento : |
documento electrónico |
| Autores : |
Juan Camilo Jaramillo Bustamante, Autor ; Lopera Múnera, Natalia, Autor ; Ortiz, Jorge, Autor ; Casson, Nils, Autor ; Iramain, Ricardo, Autor ; Pavlicich, Viviana, Autor ; Flauzino de Oliveira, Claudio, Autor ; Mozun, Rebeca, Autor ; Schlapbach, Luregn J, Autor ; Jabornisky, Roberto, Autor |
| Fecha de publicación : |
2025 |
| Títulos uniformes : |
Intensive Care Medicine – Paediatric and Neonatal
|
| Idioma : |
Inglés (eng) |
| Palabras clave : |
Adrenaline Child Inotrope Resuscitation Sepsis Septic shock |
| Resumen : |
Purpose Sepsis is a leading cause of pediatric morbidity and mortality worldwide. Current guidelines recommend fluid bolus administration of 40–60 mL/kg as part of initial resuscitation, despite limited evidence and concerns about potential harm from high fluid volumes. The ANDES-CHILD pilot study hypothesizes that early initiation of inotropes is feasible and reduces fluid use compared to standard resuscitation. Methods Multicenter open label randomized controlled pilot trial conducted in three Pediatric Emergency Departments in Latin America. Children aged 28 days to 18 years with presumed septic shock will be randomized in a 1:1 ratio to receive either early adrenaline infusion after 20 mL/kg fluid bolus versus standard resuscitation with 40–60 mL/kg fluid bolus prior to initiating inotropes. The primary outcome is feasibility, with survival free of organ support censored at 28 days as the exploratory primary clinical outcome. The study will enroll 40 patients, representing approximately 10% of a full trial, with follow-up at 28 days. Baseline characteristics, adverse events and protocol violations will be summarized descriptively. Outcomes will be analyzed using difference estimates with 95% confidence intervals. An intention-to-treat approach will be used for statistical analysis. Discussion This pragmatic pilot study will generate essential data to evaluate the feasibility and guide the design of a full trial aimed to assessing the benefits of early inotrope use in pediatric septic shock. The study was registered on ClinicalTrials.gov prior to the start of recruitment (NCT06478797). Recruitment started on July 18, 2024. |
| Mención de responsabilidad : |
Natalia Lopera-Múnera1, Jorge Ortiz2, Nils Casson3, Ricardo Iramain2, Viviana Pavlicich1, Juan Camilo Jaramillo-Bustamante, Claudio Flauzino de Oliveira, Rebeca Mozun, Luregn J Schlapbach6, and Roberto Jabornisky† |
| Referencia : |
Intensive Care Medicine – Paediatric and Neonatal |
| DOI (Digital Object Identifier) : |
10.1007/s44253-025-000 |
| Derechos de uso : |
CC BY-NC-ND |
| En línea : |
file:///C:/Users/1128458306/Downloads/Adrenaline_for_the_early_resuscitation_of_ [...] |
| Enlace permanente : |
https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_dis |
Adrenaline for the early resuscitation of children with sepsis - a randomizedcontrolled pilot study (ANDES CHILD): study protocol and analysis plan [documento electrónico] / Juan Camilo Jaramillo Bustamante, Autor ; Lopera Múnera, Natalia, Autor ; Ortiz, Jorge, Autor ; Casson, Nils, Autor ; Iramain, Ricardo, Autor ; Pavlicich, Viviana, Autor ; Flauzino de Oliveira, Claudio, Autor ; Mozun, Rebeca, Autor ; Schlapbach, Luregn J, Autor ; Jabornisky, Roberto, Autor . - 2025. Obra : Intensive Care Medicine – Paediatric and NeonatalIdioma : Inglés ( eng)
| Palabras clave : |
Adrenaline Child Inotrope Resuscitation Sepsis Septic shock |
| Resumen : |
Purpose Sepsis is a leading cause of pediatric morbidity and mortality worldwide. Current guidelines recommend fluid bolus administration of 40–60 mL/kg as part of initial resuscitation, despite limited evidence and concerns about potential harm from high fluid volumes. The ANDES-CHILD pilot study hypothesizes that early initiation of inotropes is feasible and reduces fluid use compared to standard resuscitation. Methods Multicenter open label randomized controlled pilot trial conducted in three Pediatric Emergency Departments in Latin America. Children aged 28 days to 18 years with presumed septic shock will be randomized in a 1:1 ratio to receive either early adrenaline infusion after 20 mL/kg fluid bolus versus standard resuscitation with 40–60 mL/kg fluid bolus prior to initiating inotropes. The primary outcome is feasibility, with survival free of organ support censored at 28 days as the exploratory primary clinical outcome. The study will enroll 40 patients, representing approximately 10% of a full trial, with follow-up at 28 days. Baseline characteristics, adverse events and protocol violations will be summarized descriptively. Outcomes will be analyzed using difference estimates with 95% confidence intervals. An intention-to-treat approach will be used for statistical analysis. Discussion This pragmatic pilot study will generate essential data to evaluate the feasibility and guide the design of a full trial aimed to assessing the benefits of early inotrope use in pediatric septic shock. The study was registered on ClinicalTrials.gov prior to the start of recruitment (NCT06478797). Recruitment started on July 18, 2024. |
| Mención de responsabilidad : |
Natalia Lopera-Múnera1, Jorge Ortiz2, Nils Casson3, Ricardo Iramain2, Viviana Pavlicich1, Juan Camilo Jaramillo-Bustamante, Claudio Flauzino de Oliveira, Rebeca Mozun, Luregn J Schlapbach6, and Roberto Jabornisky† |
| Referencia : |
Intensive Care Medicine – Paediatric and Neonatal |
| DOI (Digital Object Identifier) : |
10.1007/s44253-025-000 |
| Derechos de uso : |
CC BY-NC-ND |
| En línea : |
file:///C:/Users/1128458306/Downloads/Adrenaline_for_the_early_resuscitation_of_ [...] |
| Enlace permanente : |
https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_dis |
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