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New treatment option for Septic Shock
Official title Stress Hydrocortisone In Pediatric Septic Shock
ClinicalTrials.gov ID: NCT03401398
What this study is testing
What is Hydrocortisone, sodium succinate?
Hydrocortisone, sodium succinate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for septic shock.
Also referred to as SOLU-CORTEF- hydrocortisone sodium succinate injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- A child receiving treatment in a pediatric intensive care unit is eligible for recruitment into SHIPSS if she/he meets all of the following
- 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...
- 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
You likely can't join if
- 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...
- All inclusion criteria have been present for \> 12 hours
- 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 treatment clinical trial (formal assessment to be conducted by SHIPSS Core Committee for each potential...
- Etomidate or ketoconazole treatment within past 48 hours
See the full eligibility 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
- 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 \ 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.
- 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:
- All inclusion criteria have been present for \> 12 hours
- 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 treatment 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...
- 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
- 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.
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Wilmington, Delaware, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Livingston, New Jersey, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
- Memphis, Tennessee, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
- Bahia, Brazil
- Rio de Janeiro, Brazil
+ 22 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; Oakland, California, United States; Orange, California, United States; San Francisco, California, United States; Wilmington, Delaware, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.