Hydrocortisone treatment for children with septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SHIPSS trial is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that investigates the effects of adjunctive hydrocortisone in children experiencing fluid and vasoactive-inotropic refractory septic shock. The study aims to determine if hydrocortisone can reduce the incidence of new and progressive organ dysfunction and improve health-related quality of life outcomes at 28 days post-enrollment. Participants will receive either hydrocortisone or a placebo, alongside standard treatments for septic shock. The trial seeks to rigorously assess the benefits and risks associated with hydrocortisone therapy in this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Principal investigator: Jerry J Zimmerman MD, MD, PhD — Seattle Children's Hospital, University of Washington School of Medicine
• Study coordinator: Jerry J Zimmerman, MD, PhD
• Email: jerry.zimmerman@seattlechildrens.org
• Phone: 206-987-3862

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone

  In septic shock, this trial tests whether adding fludrocortisone (50 mcg or 100 mcg daily) to hydrocortisone improves survival and recovery compared with placebo.

  Recruiting at 2 sites Phase 3 The George Institute · Penrith, New South Wales and 7 other locations · NCT07898462

• Non-invasive hemodynamic guidance for sepsis care on medical wards

  This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.

  Recruiting at 2 sites Regione del Veneto - AULSS n. 7 Pedemontana · Pisa, Pisa and 1 other locations · NCT07863323

• Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter

  This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07807410

• Personalized Fluid Resuscitation in the Emergency Department

  This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.

  Recruiting Intermountain Health Care, Inc. · Murray, Utah · NCT07779720

• Discordance between capillary refill time and oxygen use in septic shock

  This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.

  Recruiting Istanbul University - Cerrahpasa · Istanbul · NCT07774962

• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

  This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.

  Recruiting Alexandria University · Alexandria, Alexandria Governorate · NCT07716956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.