What this study is
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).
What's being tested
- Hydrocortisone, sodium succinate
Intervention · DRUG
Patients randomized to the hydrocortisone treatment arm will receive an initial bolus of 2 mg/kg IV hydrocortisone, followed by 1 mg/kg (maximum 50 mg) of hydrocortisone dosed every six hours for a maximum of seven days or until all vasoactive infusions have been discontinued for at least 12 hours, whichever comes first. When the hydrocortisone course is completed, the medication will be discontinued.
- Normal saline
Intervention · DRUG
Patients randomized to the placebo treatment arm will receive an equivalent volume of normal saline, with the identical dosing schedule to the intervention (hydrocortisone) arm.
Study details
- Sponsor
- Jerry Zimmerman
- Conditions
- Septic Shock
- Enrolling
- 500 people
- Starts
- 2019-03-11
- Est. completion
- 2026-12-31
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Month – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- 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 can't join 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:
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (44)
41 openUniversity of Arizona Medical Centre
Tucson, Arizona, United States
- Katri Typpo, MD · Contact
RecruitingChildren's Hospital of Los Angeles
Los Angeles, California, United States
- Christopher Newth, MD · Contact
RecruitingUCSF Benioff Children's Hospital - Oakland
Oakland, California, United States
- Natalie Cvijanovich, MD · Contact
RecruitingChildren's Hospital of Orange County
Orange, California, United States
- Adam Schwarz, MD · Contact
RecruitingUCSF Benioff Children's Hospital - San Francisco
San Francisco, California, United States
- Patrick McQuillen, MD · ContactMcQuillP@ucsf.edu
- Matt Zinter, MD · ContactMatt.Zinter@ucsf.edu
RecruitingNemours Children's Health
Wilmington, Delaware, United States
- Catherine Madurski, MD · Contact
RecruitingUniversity of Chicago, Comer Children's Hospital
Chicago, Illinois, United States
- Grace Chong, MD · Contact
RecruitingThe University of Illinois at Chicago/OSF Children's Hospital of Illinois
Peoria, Illinois, United States
- Sandeep Tripath, MD · Contact
RecruitingUniversity of Louisville, Norton Children's Hospital
Louisville, Kentucky, United States
- John Berkenbosch, MD · Contact
RecruitingBoston Children's Hospital
Boston, Massachusetts, United States
- Michael Agus, MD · Contact
RecruitingSaint Barnabas Medical Center
Livingston, New Jersey, United States
- Shira J Gertz, MD · Contact
RecruitingCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
- Ranjit R Chima, MD · Contact
RecruitingThe Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
- Christine Allen, MD · Contact
RecruitingPenn State Milton S. Hershey Children's Hospital
Hershey, Pennsylvania, United States
- Robert Kavanagh, MD · Contact
RecruitingLe Bonheur Children's Hospital
Memphis, Tennessee, United States
- Samir Shah, MD · Contact
Not yet recruitingPrimary Children's Hospital
Salt Lake City, Utah, United States
- Jennifer Workman, MD · Contact
RecruitingSeattle Children's Hospital
Seattle, Washington, United States
- Jerry J Zimmerman, MD, PhD · Contact
RecruitingUniversity of Wisconsin Health/American Family Children's Hospital
Madison, Wisconsin, United States
- Pelin Cengiz, MD · Contact
Recruiting
26 sites outside the US
Santa Casa de Misericordia Da Bahia
Bahia, Brazil
- Rosana Novais de Carvalho, MD · Contactrosana.carvalho@santacasaba.org.br
RecruitingHospital Jutta Batista - Rio de Janeiro
Rio de Janeiro, Brazil
- Arnaldo Prata Barbosa, MD · Contactarnaldo.prata@idor.org
- Maria Carvalho Laborne Valle, MD · Contactmaria.valle@rededor.com.br
RecruitingAlberta Children's Hospital
Calgary, Alberta, Canada
- Megan Mahoney, MD · Contact
RecruitingIWK Health Centre
Halifax, Nova Scotia, Canada
- Neeraj Verma, MD · Contact
RecruitingMcMaster Children's Hospital
Hamilton, Ontario, Canada
- Karen Choong, MD · Contact
RecruitingLondon Health Sciences Centre
London, Ontario, Canada
- Douglas Fraser, MD · Contact
RecruitingChildren's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
- Kusum Menon, MD · Contact613-737-7600 ext. 2538menon@cheo.on.ca
- Katie O'Hearn, MSc · Contact613-737-7600 ext. 4006kohearn@cheo.on.ca
- James D McNally, MD, PhD · Sub-investigator
RecruitingCentre hospitalier universitaire Sainte-Justine
Montreal, Quebec, Canada
- Marisa Tucci, MD · Contact
RecruitingCentre hospitalier de l'Université Laval
Québec, Quebec, Canada
- Matthew Weiss, MD · Contact
RecruitingRambam Health Care Campus
Haifa, Israel
- Amir Hadash, MD · Contact
Not yet recruitingHadassah University Medical Center, Ein Kerem
Jerusalem, Israel
- Asaf Mandel, MD · Contact
Not yet recruitingSchneider Children's Medical Center of Israel
Petah Tikva, Israel
- Elhanan Nahum, PhD · Contact
Not yet recruitingKobe Children's Hospital
Kobe, Japan
- Hiroshi Kurosawa, MD · Contact
RecruitingAichi Children's Health and Medical Center
Nagoya, Japan
- Takanari Ikeyama, MD · Contact
RecruitingUKM Specialist Children's Hospital
Kuala Lumpur, Malaysia
- Swee Fong Tang, MD · Contact
Not yet recruitingUniversity Malaya Medical Centre
Kuala Lumpur, Malaysia
- Chin Seng Gan, MD · Contact
RecruitingSarawak General Hospital
Kuching, Malaysia
- Olive Pei Ee Lee, MD · Contact
Not yet recruitingShifa International Hospital
Islamabad, Pakistan
- Humaira Rafique, MD · Contact
- Ejaz Ahmed Khan, MD · Contact
RecruitingAga Khan University Hospital
Karachi, Pakistan
- Qalab Abbas, MD · Contact
RecruitingKing Abdullah Specialist Children's Hospital
Riyadh, Saudi Arabia
- Yasser Kazzaz, MD · Contact
RecruitingKK Women's and Children's Hospital
Singapore, Singapore
- Lee Jan Hau, MD · Contact
- Loh Sin Wee, MD · Contact
RecruitingVietnam National Children's Hospital
Hanoi, Vietnam
- Phuc Huu Phan, MD · Contact
RecruitingCity Children's Hospital
Ho Chi Minh City, Vietnam
- Nam Tran Nguyen, MD · Contact
Not yet recruitingBC Children's Hospital
Vancouver, British Columbia, Canada
TerminatedMontreal Children's Hospital
Montreal, Quebec, Canada
TerminatedRoyal University Hospital
Saskatoon, Saskatchewan, Canada
Terminated
Study team
Sponsor
Jerry Zimmerman
Study ID IRB-P00027662
Principal investigator
Jerry J Zimmerman MD, MD, PhD
Seattle Children's Hospital, University of Washington School of Medicine
Principal investigator
Michael Agus, MD
Boston Children's Hospital, Harvard Medical School
Principal investigator
Mihir R Atreya, MD, MPH
Children's Hospital Medical Center, Cincinnati
Principal investigator
David Wypij, PhD
Boston Children's Hospital, Harvard Medical School
Principal investigator
Kusum Menon, MD, MSc
Children's Hospital of Eastern Ontario
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.