Home › Trials › NCT03401398

Hydrocortisone treatment for children with septic shock

Stress Hydrocortisone In Pediatric Septic Shock

Phase 3 Interventional Seattle Children's Hospital · NCT03401398

This study is testing if hydrocortisone can help children with severe septic shock recover better and avoid further health problems.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages1 Month to 17 Years
SexAll
SponsorSeattle Children's Hospital Academic / other
Locations44 sites (Tucson, Arizona and 43 other locations)
Trial IDNCT03401398 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 month to less than 17 years and 8 months who are being treated in a pediatric intensive care unit for septic shock.

Not a fit: Patients who do not have a documented infection or strong suspicion of infection at the time of septic shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for children suffering from septic shock.

How similar studies have performed: Previous studies have shown that corticosteroids can improve hemodynamic status in sepsis, but the specific application in pediatric septic shock remains under-explored.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Tucson, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Septic Shockhydrocortisonerefractory septic shocksepsisnew/progressive MODSmortalityhealth-related quality of lifecorticosteroid adverse events
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.