Testing Hydrocortisone, sodium succinate against a placebo for septic shock
Official title: Stress Hydrocortisone In Pediatric Septic Shock
- Phase 3
- 2 groups
- Sites in Calgary, Vancouver and 7 more cities
- Recruiting
Interventions
- Medication
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.
- Medication
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.
Canadian Sites (10)
7 of 10 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
- Recruiting
IWK Health Centre
Halifax, Nova Scotia
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario
- Recruiting
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec
- Recruiting
Centre hospitalier de l'Université Laval
Québec, Quebec
- Stopped early
BC Children's Hospital
Vancouver, British Columbia
- Stopped early
Montreal Children's Hospital
Montreal, Quebec
- Stopped early
Royal University Hospital
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age is at least 1 month (with corrected gestational age ≥42 weeks), but less than 17 years and 8 months of age
- +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 criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +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.
Exclusion
- −A child receiving treatment in a pediatric intensive care unit for sepsis is ineligible for enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → into SHIPSS if she/he meets any of the following exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −All inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → 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 interventionalInterventional studyA study where participants are given something to see what happens.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (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
- −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
- −Patient documented to be pregnant
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Hydrocortisone, sodium succinate.
Registry label: A: Treatment
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Normal saline.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 1 month to 17 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 500 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: 28 days following study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
New or progressive multiple organ dysfunction syndrome as assessed utilizing the Pediatric Logistic Organ Dysfunction (PELOD-2) instrument — measured over 28 days following study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03401398 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Hydrocortisone, sodium succinateDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Normal salineDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 1 month to 17 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 1 month to 17 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 28 days following study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
The study as a whole is currently expected to finish around 2026-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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).
Other Sites (1)
Seattle Children's Hospital
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.