Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Stress Hydrocortisone In Pediatric Septic Shock
NCT03401398 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jerry Zimmerman, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03401398 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Illinois, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03401398?
The interventions under investigation include: Hydrocortisone, sodium succinate (DRUG), Normal saline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03401398?
This trial is sponsored by Jerry Zimmerman, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.