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Thanks to all Participating Centers and collaborators for engaging in this research program! Thanks to the CCCTG for endorsing this research project in Canada.

Contacts

Principal Investigator:
Dr. Kusum Menon Pager: 613-239-6580

Study Coordinator:
Katie O’Hearn Pager: 613-759-9084
 

Steroids in Fluid and/or Vasoactive Infusion Dependent Pediatric Shock –STRiPES Pilot Study

BACKGROUND: Approximately 20,000 children per year present to emergency departments, pediatric wards and intensive care units in North America with fluid and vasoactive infusion dependent shock. This severe type of shock results in significant morbidity and carries a 2-10% mortality rate depending on the setting in which it occurs. Although fluid and vasoactive agents are the mainstay of therapy, the high morbidity caused by this condition has led clinicians to utilize corticosteroids as their next line of treatment. However, although the use of steroids in this setting has been widely debated in the literature for over 40 years, there is no clear evidence to support this practice. A randomized controlled trial on the use of steroids in this condition in children is long overdue. Therefore, in collaboration with the Canadian Critical Care Trials Group, we propose to conduct a pilot randomized controlled trial on the use of steroids in pediatric shock prior to going forward with a larger, much needed, trial powered for clinically important outcomes.


 CONTACT US if you need any information about this program of research.

Study Design:

We propose a pragmatic, multi-centre, double blinded, pilot randomized controlled trial to determine the feasibility of doing a full trial on the effect of steroids versus placebo in children with fluid and vasoactive infusion dependent shock.

Setting:

Approximately 7 PICUs across Canada.

Study Population:

Children age newborn to 17 years who have been on any dose of any vasoactive infusion for 1 to 6 hours.

Study Intervention:

Patients will be randomly allocated to receive hydrocortisone or a placebo.

Outcomes:

The primary feasibility objective will be the patient accrual rate over one year.  As secondary outcomes, we will measure adherence to the protocol, the frequency of open label steroid use, the incidence of mortality and adverse events, time to discontinuation of vasoactive infusions, and the feasibility of blood sampling for mechanistic studies.
 

Steering Committee and Data Monitoring & Safety Committee:

STEERING COMMITTEE DMSC
Karen Choong, MD Dean Fergusson, PhD (DMSC Chair)
Margaret Lawson, MD Alex Ahmet, MD
Lauralyn McIntyre, MD Ari Joffe, MD
Dayre McNally, MD  
Timothy Ramsay, PhD  
Hector Wong, MD