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NCT03401398 · ClinicalTrials.gov registry record · Phase 3
Stress Hydrocortisone In Pediatric Septic Shock
A Phase 3 study of Septic Shock, sponsored by Jerry Zimmerman.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT03401398 is a Phase 3 study of Septic Shock that is actively recruiting participants, run by Jerry Zimmerman. The registered enrollment target is 500 participants, below the 5,038-participant average among 24 other Septic Shock trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT03401398, a Phase 3 study of Septic Shock, is actively recruiting participants, sponsored by Jerry Zimmerman.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 dysfunction (primary outcome) and proportion of children with poor outcomes, defined as death or severely impaired health-related quality of life (HRQL) (secondary outcome), as assessed at 28 days following study enrollment (randomization).
Conditions Studied
Interventions
- DRUG Hydrocortisone, sodium succinate
- DRUG Normal saline
Study Locations (20)
California
- Children's Hospital of Los Angeles - Los Angeles
- UCSF Benioff Children's Hospital - Oakland - Oakland
- Children's Hospital of Orange County - Orange
- UCSF Benioff Children's Hospital - San Francisco - San Francisco
Illinois
- University of Chicago, Comer Children's Hospital - Chicago
- The University of Illinois at Chicago/OSF Children's Hospital of Illinois - Peoria
Other
- Santa Casa de Misericordia Da Bahia - Bahia
- Hospital Jutta Batista - Rio de Janeiro - Rio de Janeiro
Arizona
- University of Arizona Medical Centre - Tucson
Delaware
- Nemours Children's Health - Wilmington
Kentucky
- University of Louisville, Norton Children's Hospital - Louisville
Massachusetts
- Boston Children's Hospital - Boston
New Jersey
- Saint Barnabas Medical Center - Livingston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03401398
The ClinicalTrials.gov registry entry for NCT03401398 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,038-participant average among 24 other Septic Shock trials with a reported enrollment target (90% lower). The listed sponsor is Jerry Zimmerman, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Septic Shock appearing as the primary indexed condition, and to 2 interventions - of which Hydrocortisone, sodium succinate is the first listed.
NCT03401398 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Illinois, Other.
Frequently Asked Questions
What is clinical trial NCT03401398 about?
NCT03401398 is a clinical study titled "Stress Hydrocortisone In Pediatric Septic Shock". 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 adju...
What is the current status of trial NCT03401398?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2019-03-11. Estimated completion is 2026-12-31.
What conditions does trial NCT03401398 study?
This clinical trial studies the following conditions: Septic Shock.
What interventions are being tested in trial NCT03401398?
The interventions under investigation include: Hydrocortisone, sodium succinate (DRUG), Normal saline (DRUG).
Who is sponsoring clinical trial NCT03401398?
This trial is sponsored by Jerry Zimmerman, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03401398 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.