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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: Recruiting Phase 3 study of Septic Shock, sponsored by Jerry Zimmerman.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Appearance of new or progression of existing organ dysfunctions according to PELOD-2 definitions. PELOD-2 considers 5 organ dysfunctions (neurological, cardiovascular, renal, respiratory, and hematological) with 10 total variables, with dysfunction scored 0 up to 6 for each organ category. Total minimum/maximal scores are 0/33, with increasing score indicating increasing risk of mortality. Logit (mortality) = -6.61 + 0.47 × PELOD-2 score. Probability of death = 1/(1 + exp \[-logit(mortality)\]).
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 |
What NCT03401398 shows while recruiting
NCT03401398 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 5,038-participant average among 24 other Septic Shock trials with a reported enrollment target (90% lower).
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 names 20 study sites across 15 states, led by 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
Similar trials for Septic Shock
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03401398's enrollment target sits among peer trials
500 8th of 24 higher than 17 of 24 other Septic Shock trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Septic Shock trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
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