• Canadian Critical Care Trials Group
    The Canadian Critical Care Trials Group (CCCTG) is a highly collegial group that is dedicated to the pursuit of excellence and advancement of critical care research in Canada.
  • Canadian Critical Care Trials Group
    The CCCTG has are more than 30 research programs underway and over 100 peer-reviewed publications to its credit, with direct impact on clinical practice in critical care.
  • Canadian Critical Care Trials Group
    The Canadian Critical Care Trials Group (CCCTG) is a national organization of more than 300 individuals with research interests in the management of the critically ill patient.
  • Canadian Critical Care Trials Group
    Endorsement by the CCCTG communicates our full commitment to ensure that the work is undertaken in a rigorous and ethical manner, and communicated in a timely and effective way.
Programs

Principal Investigator(s)

Coordinator(s)

Katie O’Hearn

Status

Enrolling

SHIPSS - Stress Hydrocortisone in Pediatric Septic Shock

SHIPSS - Stress Hydrocortisone in Pediatric Septic Shock

Approximately 20,000 children per year in North America present to emergency departments and pediatric wards with shock. Normally the body responds to this by producing larger amounts of a hormone called cortisol which help them heal faster. However, some children do not produce enough cortisol and/or do not respond appropriately to the cortisol that they have produce and may become very sick, needing extensive support in the pediatric intensive care unit. It is not clear as to why this happens which makes appropriate treatment of these patients difficult.
Our research consists of a multi-step program that aims to determine which patients are at risk of inadequate cortisol production and to determine the right dose and timing of cortisol replacement for them so as to provide evidence based guidelines for the treatment of these children in the future.
SHIPSS (Stress Hydrocortisone In Pediatric Septic Shock) is a prospective, randomized, double-blinded, placebo-controlled trial examining the potential benefits and risks of hydrocortisone in critically ill children with septic shock. Up to 1,032 children will be enrolled, and evaluated at baseline, PICU discharge, and 28 and 90 days following study enrollment.
The primary hypothesis is that hydrocortisone, compared to placebo, will decrease the proportion of subjects with poor outcomes, defined as death or severely impaired (≥25% decrease from baseline) health-related quality of life.

Relevant links:
• Click here to access study in Clinicaltrials.gov registry  

Relevant references:
  1. Merritt C., Menon K., Agus M.S.D, Choong K., McNally D., O’Hearn K., Watson S.,  Wong H.R., Duffett M., Wypij D., Zimmerman J.J., Beyond Survival: Pediatric Critical Care Interventional Trial Outcome Measure Preferences of Families and Healthcare Professionals. Pediatr Crit Care Med 2018 Feb;19(2):e105-e111
  2. Menon K., McNally J.D., O’Hearn K., Acharya A., Wong H.R., Lawson M., McIntyre L.,  Gilfoyle E., Tucci M., Wensley D., Gottesman R., Morrison G., Choong K. on behalf of the Canadian Critical Care Trials Group. A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock. Pediatr Crit Care Med 2017;18(6):505-512.
  3. Menon K., McNally J.D., O’Hearn K., Acharya A., Wong H.R., Lawson M., Ramsay T., McIntyre L.,  Gilfoyle E., Tucci M., Wensley D., Gottesman R., Morrison G., Choong K. A delayed consent model in a randomized trial of corticosteroids in pediatric septic shock. Pediatr Crit Care Med 2017;18(11):1009-1018.
  4. Menon K, McNally D, O’Hearn K, Zimmerman J, Agus, M, Wong H, Wypij D, Choong K. Primary Outcome Measures in Pediatric Septic Shock Trials: A Systematic Review. Pediatr Crit Care Med. 2017 Mar;18(3):e146-e154.
  5. O’Hearn K., McNally D., Choong K., Acharya A., Wong H.R., Lawson M., Ramsay T., McIntyre L., Gilfoyle E., Tucci M., Wensley D., Gottesman R., Morrison G., Menon K. The STRIPES study protocol: Steroids in fluid and/or vasoactive infusion dependent shock - A pilot randomized controlled trial of hydrocortisone versus placebo. Trials 2016;17(1):238.
  6. Menon K, McNally D, Choong K, Lawson M, Ramsay T, Wong H. A cohort study of pediatric shock: frequency of corticosteroid use and association with clinical outcomes. Shock. 2015 Nov;44(5):402-9.
  7. Menon K, McNally D, Choong K, Sampson M. A Systematic Review of Steroids in Pediatric Shock. Pediatr Crit Care Med 2013 June;14(5)474-480.
  8. Menon K, McNally D, Choong K, Lawson M, Ward R, Ramsay T, Wong H. A Survey of Physician Practices and Beliefs on the Use of Steroids in Pediatric Shock. Accepted to Pediatric Critical Care Medicine.
  9. Menon K, Ward R, Lawson M, Gaboury I, Hutchison JS, Hebert P. A Prospective Multi-Center Study of Adrenal Function in Pediatric Critical Illness. Am J Resp Crit Care Med. 2010 Jul 15;182(2):246-51. Epub Mar 18 2010.
  10. Menon K, Lawson M. Identification of Adrenal Insufficiency in Pediatric Critical Illness. Ped Crit Care Med 2007; 8(3):276-278.
  11. Menon K, Clarson C, Sim D. The Incidence of Adrenal Insufficiency in Pediatric Critical Illness. Ped Crit Care Med, 2002;3(2):112-116.

Co-Investigators

Dr. Michael Agus, Dr. Jerry Zimmerman, Dr. Hector Wong, Dr. David Wypij, Dr. Dayre McNally, Dr. Karen Choong, Dr. Tim Ramsay, Dr. Anand Acharya

Participating Centers

Canada:
Children’s Hospital of Eastern Ontario, Ottawa (Kusum Menon)
McMaster Children’s Hospital, Hamilton (Karen Choong)
London Health Sciences Centre, London (Douglas Foster)
Ste Justine Children’s Hospital, Montreal (Marisa Tucci)
Montreal Children’s Hospital, Montreal (Ronald Gottesman)
IWK Health Centre, Halifax (Neeraj Verma)
Alberta Children’s Hospital, Calgary (Elaine Gilfoyle)
Saskatoon Children’s Hospital, Saskatoon (Tanya Holt)
BC Children’s Hospital, Vancouver (Srinivas Murthy)
Centre hospitalier de l'Université Laval, Quebec City (Matthew Weiss)

United States:
Seattle Children’s Hospital, Seattle (Jerry Zimmerman)
Cincinnati Children’s Hospital, Cincinnati (Hector Wong)