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Can a steroid save kids from septic shock?

NCT ID NCT03401398

Disease control Sponsor: Jerry Zimmerman Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving the steroid hydrocortisone to children with septic shock can prevent new or worsening organ failure. About 500 children in intensive care will receive either hydrocortisone or a placebo for up to seven days. The goal is to see if this treatment improves survival and quality of life at 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydrocortisone (a steroid drug)
What this could lead to
If it works, this could provide a standard treatment to reduce organ damage and death in children with septic shock.
What could go wrong
This is a large Phase 3 trial, but steroids can have side effects like infection risk. The benefit is not yet proven, and results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 3. Surveillance cultures (e.g. blood, urine, cerebral spinal fluid, wound) and/or other microbial diagnostic tests have been obtained 4. One or more antimicrobials have been prescribed 5. 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 6. 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 7. 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. Exclusion Criteria: 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: 1. All inclusion criteria have been present for \> 12 hours 2. Attending physician expects to prescribe systemic corticosteroids for an indication other than septic shock 3. Patient has received any doses of systemic corticosteroids during treatment for sepsis 4. Enrolled concurrently in a competing interventional clinical trial (formal assessment to be conducted by SHIPSS Core Committee for each potential competing trial) 5. Etomidate or ketoconazole treatment within past 48 hours 6. Patient in whom steroids are contraindicated at time of screening (e.g. treatment for systemic fungal infection, cerebral malaria, strongyloides) 7. 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) 8. Attending physician, PICU care team, or legally recognized guardians not committed to full treatment and resuscitation at the time of screening 9. Patient documented to be pregnant 10. Previous enrollment in the SHIPSS study 11. 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. 12. (U.S. sites only) Patient in the custody of US protective services 13. Patient being evaluated for brain death 14. Vasoactive-inotropic agents prescribed solely for an indication other than septic shock 15. Confirmed dengue fever

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Conditions

The condition(s) this trial relates to.

Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aga Khan University Hospital

    RECRUITING

    Karachi, Pakistan

  • Aichi Children's Health and Medical Center

    RECRUITING

    Nagoya, Japan

  • Alberta Children's Hospital

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • BC Children's Hospital

    TERMINATED

    Vancouver, British Columbia, V6H 3N1, Canada

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Centre hospitalier de l'Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G2, Canada

  • Centre hospitalier universitaire Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Hospital of Eastern Ontario

    RECRUITING

    Ottawa, Ontario, K1H 8L1, Canada

  • Children's Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • City Children's Hospital

    NOT_YET_RECRUITING

    Ho Chi Minh City, Vietnam

  • Hadassah University Medical Center, Ein Kerem

    NOT_YET_RECRUITING

    Jerusalem, Israel

  • Hospital Jutta Batista - Rio de Janeiro

    RECRUITING

    Rio de Janeiro, Brazil

  • IWK Health Centre

    RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

  • KK Women's and Children's Hospital

    RECRUITING

    Singapore, Singapore

  • King Abdullah Specialist Children's Hospital

    RECRUITING

    Riyadh, Saudi Arabia

  • Kobe Children's Hospital

    RECRUITING

    Kobe, Japan

  • Le Bonheur Children's Hospital

    NOT_YET_RECRUITING

    Memphis, Tennessee, 38163, United States

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • McMaster Children's Hospital

    RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

  • Montreal Children's Hospital

    TERMINATED

    Montreal, Quebec, H4A 3J1, Canada

  • Nemours Children's Health

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Penn State Milton S. Hershey Children's Hospital

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Rambam Health Care Campus

    NOT_YET_RECRUITING

    Haifa, Israel

  • Royal University Hospital

    TERMINATED

    Saskatoon, Saskatchewan, S7K 1M6, Canada

  • Saint Barnabas Medical Center

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • Santa Casa de Misericordia Da Bahia

    RECRUITING

    Bahia, Brazil

  • Sarawak General Hospital

    NOT_YET_RECRUITING

    Kuching, Malaysia

  • Schneider Children's Medical Center of Israel

    NOT_YET_RECRUITING

    Petah Tikva, Israel

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Shifa International Hospital

    RECRUITING

    Islamabad, Pakistan

  • The Children's Hospital at Oklahoma University Medical Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • The University of Illinois at Chicago/OSF Children's Hospital of Illinois

    RECRUITING

    Peoria, Illinois, 61603, United States

  • UCSF Benioff Children's Hospital - Oakland

    RECRUITING

    Oakland, California, 94609, United States

  • UCSF Benioff Children's Hospital - San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • UKM Specialist Children's Hospital

    NOT_YET_RECRUITING

    Kuala Lumpur, Malaysia

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, Malaysia

  • University of Arizona Medical Centre

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Chicago, Comer Children's Hospital

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Louisville, Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Wisconsin Health/American Family Children's Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Vietnam National Children's Hospital

    RECRUITING

    Hanoi, Vietnam

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