Stress Hydrocortisone In Pediatric Septic Shock
Jerry Zimmerman
500 participants
Mar 11, 2019
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria20
- 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.
- 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
- (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
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Interventions
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.
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(44)
View Full Details on ClinicalTrials.gov
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NCT03401398