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RECRUITINGPhase 3INTERVENTIONAL

Stress Hydrocortisone In Pediatric Septic Shock

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: A child receiving treatment in a pediatric intensive care unit is eligible for recruitment into SHIPSS if she/he meets all of the following Who May Qualify: 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. Who Should NOT Join This Trial: 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 Who Should NOT Join This Trial: 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Hydrocortisone, sodium succinate

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.

DRUG

Normal saline

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.

Locations (20)

University of Arizona Medical Centre
Tucson, Arizona, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
UCSF Benioff Children's Hospital - Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, United States
Nemours Children's Health
Wilmington, Delaware, United States
University of Chicago, Comer Children's Hospital
Chicago, Illinois, United States
The University of Illinois at Chicago/OSF Children's Hospital of Illinois
Peoria, Illinois, United States
University of Louisville, Norton Children's Hospital
Louisville, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Children's Hospital
Hershey, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin Health/American Family Children's Hospital
Madison, Wisconsin, United States
Santa Casa de Misericordia Da Bahia
Bahia, Brazil
Hospital Jutta Batista - Rio de Janeiro
Rio de Janeiro, Brazil