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Title: Resuscitation in Paediatric Sepsis Using Metabolic Resuscitation-A Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU): Study Protocol and Analysis Plan.
Austin Authors: Schlapbach, Luregn J;Gibbons, Kristen;Ridolfi, Roberta;Harley, Amanda;Cree, Michele;Long, Debbie;Buckley, David;Erickson, Simon;Festa, Marino;George, Shane;King, Megan;Singh, Puneet;Raman, Sainath;Bellomo, Rinaldo 
Affiliation: Pediatric and Neonatal Intensive Care Unit, and Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland
Paediatric Intensive Care Unit, Starship Children's Hospital, Auckland, New Zealand
Intensive Care
Child Health Research Centre, The University of Queensland, and Paediatric Intensive Care Unit, Queensland Children's Hospital, Brisbane, QLD, Australia
Pharmacy Department, Queensland Children's Hospital, Brisbane, QLD, Australia
School of Nursing, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, QLD, Australia
Paediatric Critical Care Unit, Perth Children's Hospital, Perth, WA, Australia
Departments of Emergency Medicine and Children's Critical Care, Gold Coast University Hospital, Southport, QLD, Australia
School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, QLD, Australia
School of Nursing, Midwifery and Social Work, University of Queensland, Brisbane, QLD, Australia
Paediatric Intensive Care Unit, Children's Hospital Westmead, Sydney, NSW, Australia
Kids Critical Care Research Group, Kids Research, Sydney Children's Hospitals Network, Sydney, NSW, Australia
Paediatric Intensive Care Unit, Sydney Children's Hospital, Sydney, NSW, Australia
Monash University, Melbourne, VIC, Australia
Issue Date: 30-Apr-2021 2021-04-30
Publication information: Frontiers in Pediatrics 2021; 9: 663435
Abstract: Introduction: Septic shock remains amongst the leading causes of childhood mortality. Therapeutic options to support children with septic shock refractory to initial resuscitation with fluids and inotropes are limited. Recently, the combination of intravenous hydrocortisone with high dose ascorbic acid and thiamine (HAT therapy), postulated to reduce sepsis-related organ dysfunction, has been proposed as a safe approach with potential for mortality benefit, but randomized trials in paediatric patients are lacking. We hypothesize that protocolised early use of HAT therapy ("metabolic resuscitation") in children with septic shock is feasible and will lead to earlier resolution of organ dysfunction. Here, we describe the protocol of the Resuscitation in Paediatric Sepsis Using Metabolic Resuscitation-A Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU). Methods and Analysis: The RESPOND PICU study is an open label randomized-controlled, two-sided multicentre pilot study conducted in paediatric intensive care units (PICUs) in Australia and New Zealand. Sixty children aged between 28 days and 18 years treated with inotropes for presumed septic shock will be randomized in a 1:1 ratio to either metabolic resuscitation (1 mg/kg hydrocortisone q6h, 30 mg/kg ascorbic acid q6h, 4 mg/kg thiamine q12h) or standard septic shock management. Main outcomes include feasibility of the study protocol and survival free of organ dysfunction censored at 28 days. The study cohort will be followed up at 28-days and 6-months post enrolment to assess neurodevelopment, quality of life and functional status. Biobanking will allow ancillary studies on sepsis biomarkers. Ethics and Dissemination: The study received ethical clearance from Children's Health Queensland Human Research Ethics Committee (HREC/18/QCHQ/49168) and commenced enrolment on June 12th, 2019. The primary study findings will be submitted for publication in a peer-reviewed journal. Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN12619000829112). Protocol Version: V1.8 22/7/20.
DOI: 10.3389/fped.2021.663435
PubMed URL: 34041208
ISSN: 2296-2360
Type: Journal Article
Subjects: ascorbic acid
intensive care
septic shock
vitamin C
Appears in Collections:Journal articles

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