TY - JOUR
T1 - Early Resuscitation in Paediatric Sepsis Using Inotropes – A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): v
AU - Harley, Amanda
AU - George, Shane
AU - King, Megan
AU - Phillips, Natalie
AU - Keijzers, Gerben
AU - Long, Debbie
AU - Gibbons, Kristen
AU - Bellomo, Rinaldo
AU - Schlapbach, Luregn J.
AU - RESPOND ED study group
N1 - Funding Information:
The authors would like to thank the parents and children participating in this trial and the medical, nursing and study teams in the participating sites for their help in study setup, recruitment, data collection and monitoring of study data. Funding. LS was supported by a National Health and Medical Research Council (NHMRC) Practitioner Fellowship and by the Children's Hospital Foundation, Australia. The study was supported by grants from the Emergency Medicine Foundation Queensland, Financial Markets for Children Australia, the Gold Coast Hospital Foundation, and by a Children's Health Queensland SERTA grant.
Funding Information:
LS was supported by a National Health and Medical Research Council (NHMRC) Practitioner Fellowship and by the Children’s Hospital Foundation, Australia. The study was supported by grants from the Emergency Medicine Foundation Queensland, Financial Markets for Children Australia, the Gold Coast Hospital Foundation, and by a Children’s Health Queensland SERTA grant.
Publisher Copyright:
© Copyright © 2021 Harley, George, King, Phillips, Keijzers, Long, Gibbons, Bellomo and Schlapbach.
PY - 2021/5/31
Y1 - 2021/5/31
N2 - Introduction: Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40–60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. We hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, we describe the protocol of the Early Resuscitation in Paediatric Sepsis Using Inotropes – A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED). Methods and analysis: The RESPOND ED study is an open label randomised controlled, two arm, multicentre pilot study conducted at four specialised paediatric Emergency Departments. Forty children aged between 28 days and 18 years treated for presumed septic shock will be randomized in a 1:1 ratio to early inotropes vs. standard fluid resuscitation. Early inotrope treatment is defined as the commencement of a continuous intravenous adrenaline infusion after 20 mL/kg fluid bolus resuscitation. Standard fluid resuscitation is defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to commencement of inotropes. In addition to feasibility outcomes, survival free of organ dysfunction censored at 28 days will be assessed as the main clinical outcome. The study cohort will be followed up at 28 days, and at 6 months post enrolment to assess quality of life and functional status. Biobanking nested in the study cohort will be performed to enable ancillary biomarker studies. Ethics and dissemination: The trial has ethical clearance (Children's Health Queensland, Brisbane, HREC/18/QCHQ/49168) and is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619000828123). Enrolment commenced on July 21st, 2019. The primary manuscript will be submitted for publication in a peer-reviewed journal. Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12619000828123.
AB - Introduction: Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40–60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. We hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, we describe the protocol of the Early Resuscitation in Paediatric Sepsis Using Inotropes – A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED). Methods and analysis: The RESPOND ED study is an open label randomised controlled, two arm, multicentre pilot study conducted at four specialised paediatric Emergency Departments. Forty children aged between 28 days and 18 years treated for presumed septic shock will be randomized in a 1:1 ratio to early inotropes vs. standard fluid resuscitation. Early inotrope treatment is defined as the commencement of a continuous intravenous adrenaline infusion after 20 mL/kg fluid bolus resuscitation. Standard fluid resuscitation is defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to commencement of inotropes. In addition to feasibility outcomes, survival free of organ dysfunction censored at 28 days will be assessed as the main clinical outcome. The study cohort will be followed up at 28 days, and at 6 months post enrolment to assess quality of life and functional status. Biobanking nested in the study cohort will be performed to enable ancillary biomarker studies. Ethics and dissemination: The trial has ethical clearance (Children's Health Queensland, Brisbane, HREC/18/QCHQ/49168) and is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619000828123). Enrolment commenced on July 21st, 2019. The primary manuscript will be submitted for publication in a peer-reviewed journal. Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12619000828123.
UR - http://www.scopus.com/inward/record.url?scp=85107937689&partnerID=8YFLogxK
U2 - 10.3389/fped.2021.663028
DO - 10.3389/fped.2021.663028
M3 - Article
AN - SCOPUS:85107937689
SN - 2296-2360
VL - 9
JO - Frontiers in Pediatrics
JF - Frontiers in Pediatrics
M1 - 663028
ER -