Stress Hydrocortisone In Pediatric Septic Shock

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Septic Shock

In brief

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).

Key facts

Study ID

NCT03401398

Run by

Jerry Zimmerman

People needed

500

Starts

2019-03-11

Expected to finish

2026-12-31

Last updated by the study team

2025-10-30

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Age is at least 1 month (with corrected gestational age ≥42 weeks), but less than 17 years and 8 months of age
• A documented focus of infection or a strong suspicion of infection at PICU admission, or for patients who develop septic shock during PICU stay, at the onset of the septic shock event
• Surveillance cultures (e.g. blood, urine, cerebral spinal fluid, wound) and/or other microbial diagnostic tests have been obtained
• One or more antimicrobials have been prescribed
• Core temperature >38.5 C or <36.0 C or leukocytosis or leukopenia (as defined by the local laboratory) or a left-shifted leukocyte differential (>10% immature granulocyte forms) or a neutrophil count of <0.5 x 109 cells per litre documented at least once within the 24 hours preceding screening
• Treatment with a continuous infusion of vasoactive-inotropic agent(s) to maintain mean or systolic arterial blood pressure above the age-appropriate target set by the treating clinician
• Administration of two or more vasoactive-inotropic agents at any dose or epinephrine or norepinephrine infusion(s) alone at greater than or equal to 0.10 mcg/kg/min for >1 hour.

You may not qualify if…

• A child receiving treatment in a pediatric intensive care unit for sepsis is ineligible for enrollment into SHIPSS if she/he meets any of the following exclusion criteria:
• All inclusion criteria have been present for > 12 hours
• Attending physician expects to prescribe systemic corticosteroids for an indication other than septic shock
• Patient has received any doses of systemic corticosteroids during treatment for sepsis
• Enrolled concurrently in a competing interventional clinical trial (formal assessment to be conducted by SHIPSS Core Committee for each potential competing trial)
• Etomidate or ketoconazole treatment within past 48 hours
• Patient in whom steroids are contraindicated at time of screening (e.g. treatment for systemic fungal infection, cerebral malaria, strongyloides)
• Known or suspected hypothalamic, pituitary or adrenal disease (including patient has received acute or chronic corticosteroid administration and the physician intends to provide corticosteroid for suspected adrenal suppression)
• Attending physician, PICU care team, or legally recognized guardians not committed to full treatment and resuscitation at the time of screening
• Patient documented to be pregnant
• Previous enrollment in the SHIPSS study
• Patient admitted directly to the PICU with a thermal burn who has been in the PICU for <72 hours prior to meeting SHIPSS inclusion criteria.
• (U.S. sites only) Patient in the custody of US protective services
• Patient being evaluated for brain death
• Vasoactive-inotropic agents prescribed solely for an indication other than septic shock
• Confirmed dengue fever

Where it is running

• Kobe Children's Hospital — Kobe, Japan (enrolling)
• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• UCSF Benioff Children's Hospital - Oakland — Oakland, California, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• UCSF Benioff Children's Hospital - San Francisco — San Francisco, California, United States (enrolling)
• Nemours Children's Health — Wilmington, Delaware, United States (enrolling)
• University of Chicago, Comer Children's Hospital — Chicago, Illinois, United States (enrolling)
• The University of Illinois at Chicago/OSF Children's Hospital of Illinois — Peoria, Illinois, United States (enrolling)
• University of Louisville, Norton Children's Hospital — Louisville, Kentucky, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Saint Barnabas Medical Center — Livingston, New Jersey, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• The Children's Hospital at Oklahoma University Medical Center — Oklahoma City, Oklahoma, United States (enrolling)
• Penn State Milton S. Hershey Children's Hospital — Hershey, Pennsylvania, United States (enrolling)
• Centre hospitalier universitaire Sainte-Justine — Montreal, Quebec, Canada (enrolling)
• Centre hospitalier de l'Université Laval — Québec, Quebec, Canada (enrolling)
• University of Arizona Medical Centre — Tucson, Arizona, United States (enrolling)
• Aichi Children's Health and Medical Center — Nagoya, Japan (enrolling)
• University Malaya Medical Centre — Kuala Lumpur, Malaysia (enrolling)
• Shifa International Hospital — Islamabad, Pakistan (enrolling)
• Aga Khan University Hospital — Karachi, Pakistan (enrolling)
• King Abdullah Specialist Children's Hospital — Riyadh, Saudi Arabia (enrolling)
• KK Women's and Children's Hospital — Singapore, Singapore (enrolling)
• Vietnam National Children's Hospital — Hanoi, Vietnam (enrolling)
• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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