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Published on: April 26, 2015

Resuscitation in paediatric septic shock using vitamin C and hydrocortisone (RESPOND): The RESPOND randomised

Kristen S Gibbons1, Sainath Raman1,2, Lalitha Av3

  • 1Children's Intensive Care Research Program, Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.

Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
|June 24, 2026
PubMed

Insights

The Resuscitation in Paediatric Septic Shock using Vitamin C and Hydrocortisone (RESPOND) trial investigates if hydrocortisone with or without vitamin C improves outcomes for critically ill children. This study presents the statistical analysis plan for this important pediatric septic shock research.

Area of Science:

  • Pediatric Critical Care Medicine
  • Clinical Trials Methodology
  • Septic Shock Pathophysiology

Background:

  • Pediatric septic shock is a life-threatening condition requiring intensive management.
  • Current treatments aim to improve hemodynamics and organ function.
  • The role of hydrocortisone and vitamin C in pediatric septic shock requires further investigation.

Purpose of the Study:

  • To present the prespecified statistical analysis plan (SAP) for the Resuscitation in Paediatric Septic Shock using Vitamin C and Hydrocortisone (RESPOND) trial.
  • To outline the methodology for analyzing the primary and secondary outcomes before data locking.
  • To ensure transparency and verifiability of the trial's statistical approach.

Main Methods:

  • A multicentre, three-arm, parallel group, open-label randomized controlled trial.
  • Recruitment of 384 participants in pediatric intensive care units across Australia, New Zealand, India, and Brazil.
  • Primary outcome: time alive and free of inotropes/vasopressors within 7 days; secondary outcomes include clinical, safety, economic, and long-term measures.

Main Results:

  • The statistical analysis plan details the methods for analyzing the primary outcome using quantile regression.
  • Secondary outcomes will be analyzed using appropriate statistical comparisons.
  • The SAP ensures a transparent, verifiable, and predetermined analytical approach.

Conclusions:

  • The RESPOND trial's SAP provides a robust framework for evaluating the efficacy of hydrocortisone with or without vitamin C in pediatric septic shock.
  • The study design and analysis plan are finalized prior to recruitment completion.
  • This rigorous approach will yield reliable data on treatment effectiveness and patient outcomes.
Abstract

Keywords:
ChildClinical trialCritically illSeptic shockVitamin C

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