Phase 4
Completed N=57
Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study
Source: ClinicalTrials.gov NCT02044159 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Patient Accrual Rate Over One Year (% of Target Sample Size Achieved) — 82 percentage of target sample size
◆ Published Evidence
Emerging
13citations · ~1 / year
Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial.
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.
Linked Publications
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Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Accrual Rate Over One Year (% of Target Sample Size Achieved) |
82 | — |
| SECONDARY 1a. Time to Administration of the First Dose of Study Drug |
3.8 | — |
| SECONDARY 1b. Weaning of Study Drug to q8h When Patient is Hemodynamically Stable |
97.6 | — |
| SECONDARY 1c. Discontinuation of Study Drug When Off All Vasoactive Medications |
97.6 | — |
| SECONDARY Number of Patients Started on Open Label Steroids by the Treating Physician |
6 | — |
| SECONDARY Time to Discontinuation of Vasoactive Infusions |
38.2; 33.1 | — |
| SECONDARY Number of Participants With Incidence of Adverse Events and Mortality in the Full Cohort |
24 | — |
| SECONDARY Percentage of Patients for Whom Blood Samples Are Sent, and Successfully Received and Analyzed in Their Respective Labs |
44 | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT02044159) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.