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Hydrocortisone for Pediatric Septic Shock (SHIPSS Trial)
SHIPSS Trial Summary
This trial will test if hydrocortisone can help children with septic shock who are not responding to other treatments.
SHIPSS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSHIPSS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SHIPSS Trial Design
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Who is running the clinical trial?
Media Library
- I have or might have a condition affecting my hormone glands and may need steroids.I am younger than 17 years and 8 months old.I have been prescribed antibiotics.Steroids are not safe for me due to my current medical conditions.I have been given two or more heart medications or high-dose adrenaline infusions for over an hour.My doctor plans to prescribe me steroids for a reason other than septic shock.My primary injury is a burn from heat.I was admitted to the PICU due to an infection or suspected infection.I have not taken etomidate or ketoconazole in the last 48 hours.I have been treated with corticosteroids for sepsis.I am on a continuous drip medication to keep my blood pressure up.
- Group 1: Treatment
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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"
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."
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."
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."
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