Stress Hydrocortisone In Pediatric Septic Shock
Recruiting
Phase 3
Interventional Study
Septic Shock
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Jerry Zimmerman · Other
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About This Trial
SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that will examine the potential benefits and risks of adjunctive hydrocortisone prescribed for children with fluid and vasoactive-inotropic refractory septic shock.
It is hypothesized that adjunctive hydrocortisone will significantly reduce the incidence of new and progressive organ dysfuncti…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
A child receiving treatment in a pediatric intensive care unit is eligible for recruitment into SHIPSS if she/he meets all of the following inclusion criteria:
1. Age is at least 1 month (with corrected gestational age ≥42 weeks), but less than 17 years and 8 months of age
2. A…
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