Stress Hydrocortisone In Pediatric Septic Shock

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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 proportion of children with poor outcomes, defined as death or severely impaired health-related quality of life (HRQL), as assessed at 28 days following study enrollment (randomization).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jerry Zimmerman
• Collaborators: Canadian Critical Care Trials Group; Canadian Institutes of Health Research (CIHR); Children's Hospital of Eastern Ontario; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

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. Primary disease/injury is a thermal burn

12. (U.S. sites only) Patient in the custody of US protective services.