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Hydrocortisone for Pediatric Septic Shock (SHIPSS Trial)

Phase 3
Recruiting
Led By Jerry J Zimmerman MD, MD, PhD
Research Sponsored by Jerry Zimmerman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age is at least 1 month (with corrected gestational age ≥42 weeks), but less than 17 years and 8 months of age
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 and 90 days following study enrollment
Awards & highlights

SHIPSS Trial Summary

This trial will test if hydrocortisone can help children with septic shock who are not responding to other treatments.

Who is the study for?
This trial is for children aged 1 month to less than 17 years and 8 months with severe septic shock, who have had certain tests done, are on multiple medications to support blood pressure, and show signs of infection. It's not for those treated with specific drugs recently, pregnant, in US protective custody, or with certain diseases like adrenal disorders.Check my eligibility
What is being tested?
The SHIPSS study is testing if hydrocortisone can help kids with septic shock get better outcomes compared to a normal saline placebo. Kids will be randomly assigned to either the drug or placebo group without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects from hydrocortisone may include changes in blood sugar levels, increased risk of infections due to weakened immune response, stomach ulcers, mood swings or behavior changes.

SHIPSS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am younger than 17 years and 8 months old.
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I have been given two or more heart medications or high-dose adrenaline infusions for over an hour.
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I was admitted to the PICU due to an infection or suspected infection.
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I am on a continuous drip medication to keep my blood pressure up.

SHIPSS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 and 90 days following study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 and 90 days following study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
28-day hospital mortality or ≥25% decrease from baseline in health-related quality of life (HRQL) assessed utilizing the Pediatric Quality of Life Inventory, (PedsQL)
Secondary outcome measures
New or progressive multiple organ dysfunction syndrome as assessed utilizing the Pediatric Logistic Organ Dysfunction (PELOD-2) instrument.
Other outcome measures
90-Day Death or ≥25% decrease in HRQL from baseline
Cost Analysis - Cost of PICU admission for septic shock
Disruption of family dynamics
+14 more

SHIPSS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TreatmentActive Control1 Intervention
Approximately half of the subjects randomized into SHIPSS will be randomized into the Treatment Group and will receive hydrocortisone sodium succinate according to a predetermined dosing schedule.
Group II: PlaceboPlacebo Group1 Intervention
Approximately half of the subjects randomized into SHIPSS will be randomized into the Placebo Group and will receive equivalent study drug volumes of normal saline.

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Who is running the clinical trial?

Jerry ZimmermanLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,671,188 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,076 Total Patients Enrolled
7 Trials studying Septic Shock
1,773 Patients Enrolled for Septic Shock

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT03401398 — Phase 3
Septic Shock Research Study Groups: Treatment, Placebo
Septic Shock Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT03401398 — Phase 3
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03401398 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this particular medication legally allowed to be administered by medical professionals?

"There is some evidence from earlier phases of this trial that suggest the treatment may be effective and there are multiple rounds of data supporting safety, so it received a score of 3."

Answered by AI

Is this a new line of research or has this been looked into before?

"This treatment was first studied in 1995 at the National Institutes of Health Clinical Center. A total of 418 clinical trials have been completed to date, with 64 active studies currently underway. Many of these are located in Québec, Quebec."

Answered by AI

Are there any specific prerequisites for people who want to join this clinical trial?

"This study is looking for 1032 individuals who are currently in shock and meet the following age, treatment, and health requirements: being between 1 month and 17 years old (42 weeks of gestational age or more), receiving continuous infusions of vasoactive-inotropic agents to maintain blood pressure above an age-appropriate target set by their clinician, having a documented focus of infection or strong suspicion of infection at PICU admission or developing septic shock during their PICU stay, surveillance cultures and/or other microbial diagnostic tests have been obtained, one or more antimicrobials have been prescribed, a core temperature that is"

Answered by AI

Is this a currently enrolling clinical trial?

"From what is listed on clinicaltrials.gov, this particular trial is still looking for participants and actively recruiting. The original posting date was March 11th, 2019 with the latest update being October 25th, 2022."

Answered by AI

Does this research project allow for participants that are over the age of 50?

"This research study is only for children aged 1 month to 17 years old. Out of the 234 clinical trials currently underway, this one is specifically designed for young patients."

Answered by AI

What are the main disorders that this remedy is designed to target?

"Mesalamine is a medication that is commonly used to treat ulcerative colitis. It can also be used off-label to manage varicella-zoster virus acute retinal necrosis, brain, iritis."

Answered by AI
~238 spots leftby Sep 2025