Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Approximately 20,000 children per year in North America present to the hospital with severe shock. Children who develop this condition have very low blood pressures and as a result may suffer damage to their internal organs and may even die. Some children with this condition may significantly benefit from the use of steroids but steroids in such patients may also have potential side effects. Therefore it is important to study the use of steroids carefully in these children. The STRIPES research program will examine the effectiveness and safety of steroids in children. Before conducting a large, randomized controlled trial (RCT), a pilot study (STRIPES Pilot Study) will be conducted in multiple sites across Canada. The STRIPES Pilot Study will allow testing of the STRIPES study protocol in a smaller group of patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Eastern Ontario
• Collaborators: Alberta Children's Hospital; British Columbia Children's Hospital; IWK Health Centre; London Health Sciences Centre; Montreal Children's Hospital of the MUHC; St. Justine's Hospital
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

• Children newborn to 17 years

• On any dose of any vasoactive infusion for between 1 to 6 hours

Exclusion Criteria:

• Patients who have known or suspected hypothalamic, pituitary or adrenal disease

• Patients who are currently receiving steroids for the treatment of shock/suspected shock prior to randomization

• Patients who are expected to have treatment withdrawn

• Patients who are premature infants (<38 weeks corrected gestational age)

• Patients who are pregnant

• Patients post cardiac surgery

• Patient who received their first dose of vasoactive infusion >24 hours after PICU admission

• Patient who is no longer on vasoactive infusion at the time of study enrollment, and/or is expected to no longer be on vasoactive infusion at the time the first dose of study drug will be administered

• Patients for whom primary cardiogenic shock is strongly suspected

• Patients for whom spinal shock is strongly suspected

• Patients for whom hemorrhagic or hypovolemic shock is strongly suspected

• Patients who were previously enrolled in the STRIPES study

• Patients who receive a vasoactive agent for reasons not related to shock

• Physician refusal