Clinical trialNCT03401398RecruitingPhase 3Interventional

Stress Hydrocortisone In Pediatric Septic Shock

SponsorJerry ZimmermanEnrollment500Septic Shock

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

David Wypij, PhD
Boston Children's Hospital, Harvard Medical School
Principal Investigator
clinicaltrials.gov ↗
Jerry J Zimmerman MD, MD, PhD
Seattle Children's Hospital, University of Washington School of Medicine
Principal Investigator
clinicaltrials.gov ↗
Kusum Menon, MD, MSc
Children's Hospital of Eastern Ontario
Principal Investigator
clinicaltrials.gov ↗
Michael Agus, MD
Boston Children's Hospital, Harvard Medical School
Principal Investigator
clinicaltrials.gov ↗
Mihir R Atreya, MD, MPH
Children's Hospital Medical Center, Cincinnati
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

44 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil

Santa Casa de Misericordia Da Bahia
Bahia, Brazil
Recruiting
Hospital Jutta Batista - Rio de Janeiro
Rio de Janeiro, Brazil
Recruiting

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
Recruiting
Bc Children'S Hospital
Vancouver, British Columbia, Canada
Terminated
Iwk Health Centre
Halifax, Nova Scotia, Canada
Recruiting
Mcmaster Children'S Hospital
Hamilton, Ontario, Canada
Recruiting
London Health Sciences Centre
London, Ontario, Canada
Recruiting
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
James D McNally, MD, PhD
Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Recruiting
Montreal Children'S Hospital
Montreal, Quebec, Canada
Terminated
Centre Hospitalier de L'Université Laval
Québec, Quebec, Canada
Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Terminated

Israel

Rambam Health Care Campus
Haifa, Israel
Not, yet, recruiting
Hadassah University Medical Center, Ein Kerem
Jerusalem, Israel
Not, yet, recruiting
Schneider Children'S Medical Center of Israel
Petah Tikva, Israel
Not, yet, recruiting

Japan

Kobe Children'S Hospital
Kobe, Japan
Recruiting
Aichi Children'S Health and Medical Center
Nagoya, Japan
Recruiting

Malaysia

Ukm Specialist Children'S Hospital
Kuala Lumpur, Malaysia
Not, yet, recruiting
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Recruiting
Sarawak General Hospital
Kuching, Malaysia
Not, yet, recruiting

Pakistan

Shifa International Hospital
Islamabad, Pakistan
Recruiting
Aga Khan University Hospital
Karachi, Pakistan
Recruiting

Saudi Arabia

King Abdullah Specialist Children'S Hospital
Riyadh, Saudi Arabia
Recruiting

Singapore

Kk Women'S and Children'S Hospital
Singapore, Singapore
Recruiting

United States

University of Arizona Medical Centre
Tucson, Arizona, United States
Recruiting
Children'S Hospital of Los Angeles
Los Angeles, California, United States
Recruiting
Ucsf Benioff Children'S Hospital - Oakland
Oakland, California, United States
Recruiting
Children'S Hospital of Orange County
Orange, California, United States
Recruiting
Ucsf Benioff Children'S Hospital - San Francisco
San Francisco, California, United States
Recruiting
Nemours Children'S Health
Wilmington, Delaware, United States
Recruiting
University of Chicago, Comer Children'S Hospital
Chicago, Illinois, United States
Recruiting
the University of Illinois at Chicago/osf Children'S Hospital of Illinois
Peoria, Illinois, United States
Recruiting
University of Louisville, Norton Children'S Hospital
Louisville, Kentucky, United States
Recruiting
Boston Children'S Hospital
Boston, Massachusetts, United States
Recruiting
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Recruiting
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Recruiting
the Children'S Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Recruiting
Penn State Milton S. Hershey Children'S Hospital
Hershey, Pennsylvania, United States
Recruiting
Le Bonheur Children'S Hospital
Memphis, Tennessee, United States
Not, yet, recruiting
Primary Children'S Hospital
Salt Lake City, Utah, United States
Recruiting

4 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

HydrocortisoneNormal saline

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 Mar 2019
Primary completion: 30 Sept 2026
Completion: 31 Dec 2026
Last update posted: 30 Oct 2025
Registered enrollment: 500
Registry id: NCT03401398

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.