Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study
Condition: Shock
MeSH terms: Shock
Intervention: Hydrocortisone; Placebo
Intervention description: Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg).; The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone).
Intervention MeSH terms: Hydrocortisone; Hydrocortisone hemisuccinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 1 Day
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hydrocortisone; Pediatrics; Adrenal Insufficiency

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.
    

Eligibility 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          -  Patients who are expected to have treatment withdrawn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