Actively Recruiting
Stress Hydrocortisone In Pediatric Septic Shock
Led by Jerry Zimmerman · Updated on 2025-10-30
500
Participants Needed
44
Research Sites
407 weeks
Total Duration
On this page
Sponsors
J
Jerry Zimmerman
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Stress Hydrocortisone In Pediatric Septic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 1 month (corrected gestational age ≥42 weeks) but less than 17 years and 8 months
- Documented or strongly suspected infection at PICU admission or at septic shock onset
- Surveillance cultures or microbial diagnostic tests obtained
- At least one antimicrobial prescribed
- Fever >38.5°C or <36.0°C, or abnormal white blood cell counts documented within 24 hours before screening
- Receiving continuous infusion of vasoactive-inotropic agents to maintain blood pressure above age-appropriate target
- Receiving two or more vasoactive-inotropic agents or epinephrine/norepinephrine infusion ≥0.10 mcg/kg/min for over 1 hour
You will not qualify if you...
- All inclusion criteria present for more than 12 hours
- Expected use of systemic corticosteroids for reasons other than septic shock
- Received any systemic corticosteroids during sepsis treatment
- Concurrent enrollment in a competing interventional clinical trial
- Received etomidate or ketoconazole in past 48 hours
- Steroids contraindicated (e.g. systemic fungal infection, cerebral malaria, strongyloides)
- Known or suspected hypothalamic, pituitary, or adrenal disease or corticosteroid use indicating adrenal suppression
- Not committed to full treatment and resuscitation by physician, care team, or guardians
- Documented pregnancy
- Previous enrollment in this study
- Direct PICU admission with thermal burn and PICU stay less than 72 hours before meeting inclusion
- (U.S. sites only) Patient in custody of U.S. protective services
- Being evaluated for brain death
- Vasoactive-inotropic agents prescribed only for conditions other than septic shock
- Confirmed dengue fever
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
University of Arizona Medical Centre
Tucson, Arizona, United States, 85724
Actively Recruiting
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
UCSF Benioff Children's Hospital - Oakland
Oakland, California, United States, 94609
Actively Recruiting
4
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
5
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
6
Nemours Children's Health
Wilmington, Delaware, United States, 19803
Actively Recruiting
7
University of Chicago, Comer Children's Hospital
Chicago, Illinois, United States, 60637
Actively Recruiting
8
The University of Illinois at Chicago/OSF Children's Hospital of Illinois
Peoria, Illinois, United States, 61603
Actively Recruiting
9
University of Louisville, Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
10
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
13
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
14
Penn State Milton S. Hershey Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
15
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38163
Not Yet Recruiting
16
Primary Children's Hospital
Salt Lake City, Utah, United States, 84108
Actively Recruiting
17
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
18
University of Wisconsin Health/American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
19
Santa Casa de Misericordia Da Bahia
Bahia, Brazil
Actively Recruiting
20
Hospital Jutta Batista - Rio de Janeiro
Rio de Janeiro, Brazil
Actively Recruiting
21
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
22
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Terminated
23
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
24
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
25
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
26
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
27
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
28
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
Terminated
29
Centre hospitalier de l'Université Laval
Québec, Quebec, Canada, G1V 4G2
Actively Recruiting
30
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7K 1M6
Terminated
31
Rambam Health Care Campus
Haifa, Israel
Not Yet Recruiting
32
Hadassah University Medical Center, Ein Kerem
Jerusalem, Israel
Not Yet Recruiting
33
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
Not Yet Recruiting
34
Kobe Children's Hospital
Kobe, Japan
Actively Recruiting
35
Aichi Children's Health and Medical Center
Nagoya, Japan
Actively Recruiting
36
UKM Specialist Children's Hospital
Kuala Lumpur, Malaysia
Not Yet Recruiting
37
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Actively Recruiting
38
Sarawak General Hospital
Kuching, Malaysia
Not Yet Recruiting
39
Shifa International Hospital
Islamabad, Pakistan
Actively Recruiting
40
Aga Khan University Hospital
Karachi, Pakistan
Actively Recruiting
41
King Abdullah Specialist Children's Hospital
Riyadh, Saudi Arabia
Actively Recruiting
42
KK Women's and Children's Hospital
Singapore, Singapore
Actively Recruiting
43
Vietnam National Children's Hospital
Hanoi, Vietnam
Actively Recruiting
44
City Children's Hospital
Ho Chi Minh City, Vietnam
Not Yet Recruiting
Research Team
J
Jerry J Zimmerman, MD, PhD
CONTACT
K
Kusum Menon, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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