Table 1 World Health Organization trial registration data set: structured summary
Data category | Information |
|---|---|
Primary registry, trial identifying number | ClinicalTrials.gov identifier NCT02044159 |
Date of registration in primary registry | January 21, 2014 |
Secondary identifying numbers | CHEO REB 14/05E |
Protocol version | Version 5, May 7, 2015 |
Sources of monetary support | Canadian Institutes of Health Research Operating Grant |
Primary sponsor | Investigator-initiated study |
Kusum Menon (KM) | |
Children’s Hospital of Eastern Ontario | |
401 Smyth Road | |
Ottawa, Ontario | |
K1H 8 L1 | |
Phone: 613-737-7600 ext. 2538 | |
Email: menon@cheo.on.ca | |
Secondary sponsor | Children’s Hospital of Eastern Ontario Research Institute |
Contact for public queries | KM, Pediatric Critical Care, Children’s Hospital of Eastern Ontario, Ottawa, Canada |
Contact for scientific queries | KM, Pediatric Critical Care, Children’s Hospital of Eastern Ontario, Ottawa, Canada |
Public title | Steroids in Fluid and Vasoactive Infusion Dependent Shock (STRIPES) pilot study |
Scientific title | Steroids in Fluid and Vasoactive Infusion Dependent Shock (STRIPES) pilot study |
Country of recruitment | Canada, multi- academic center (7) study |
Health problem under investigation | Efficacy and safety of hydrocortisone as a treatment of fluid and vasoactive infusion dependent shock |
Key inclusion and exclusion criteria | Eligible for study: started on a vasoactive infusion within 24 h of PICU admission |
Inclusion criteria: newborn to 17 years of age, receiving vasoactive infusions for 1–6 h | |
Exclusion criteria: known or suspected hypothalamic, pituitary or adrenal disease; currently receiving steroids for shock prior to randomization; are expected to have treatment withdrawn; post cardiac surgery; primary cardiogenic shock, spinal shock, hemorrhagic, or hypovolemic shock proven or strongly suspected; previously enrolled in the STRIPES study; steroids started for reasons other than shock; no longer on inotropes at the time of randomization or first dose of study drug; or physician refusal | |
Study type | Pragmatic, multi-center, double-blind, pilot randomized controlled trial |
Date of first enrollment | September 4, 2014 |
Target sample size | 72 |
Recruitment status | Recruiting as of July 2014 |
Primary outcome | Patient accrual rate over a 1-year recruitment period |
Key secondary outcomes | Adherence to the study protocol; frequency of open-label corticosteroid use and the clinical characteristic of patients in whom open-label corticosteroids are used; incidence of mortality and adverse events; time to discontinuation of inotropes; and the feasibility of mechanistic blood sampling |