Stress Hydrocortisone In Pediatric Septic Shock

Launched by JERRY ZIMMERMAN · Jan 15, 2018

Keywords

ClinConnect Summary

The SHIPSS trial is studying whether giving hydrocortisone, a type of steroid, can help children who are suffering from septic shock, a serious condition caused by severe infections. The researchers want to find out if hydrocortisone can lower the chances of new or worsening organ problems in these children and improve their overall health outcomes after 28 days. This study is taking place at multiple hospitals and involves randomly assigning participants to either receive hydrocortisone or a placebo (a treatment that looks like the real thing but has no active ingredients).

To be eligible for this trial, children aged between 1 month and 17 years who are being treated in a pediatric intensive care unit (PICU) must show signs of a serious infection and require medications to support their blood pressure. There are specific criteria to ensure the safety of participants, such as not having received steroids for other conditions or being part of another clinical trial at the same time. If a child qualifies and agrees to participate, they will receive close monitoring and care as part of this important research aimed at improving treatments for septic shock.

Gender

ALL

Eligibility 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