Status:
COMPLETED
Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis - a Randomised Pilot Study
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Imperial College London
St Mary's NHS Trust
Conditions:
Sepsis
Eligibility:
All Genders
3-14 years
Phase:
PHASE2
Brief Summary
Severe bacterial infections affecting multiple body organs, called severe sepsis (including meningococcal sepsis), remain an important cause of death and disability among children. Although early reco...
Detailed Description
1. PURPOSE: The Need for a Paediatric Trial of Steroids in Sepsis - potential benefits and risks Numerous targets for new therapies in sepsis have been identified, none of which have been shown to hav...
Eligibility Criteria
Inclusion
- Severe sepsis where enrolment can occur within 20 hours of first contact with paediatric intensive care, or within 20 hours of the diagnosis of severe sepsis when this diagnosis is made on PICU. Randomisation should occur within 24 hours of first contact with paediatric intensive care, or within 24 hours of the diagnosis of severe sepsis when this diagnosis is made on PICU.
- Requiring mechanical ventilation (The subjects must be mechanically ventilated for entry into the study but this is not time limited. It is routine practice at study centres to pre-emptively ventilate children with evolving sepsis)
Exclusion
- Concomitant steroid therapy, vasopressor treatment \>24 hrs or use of etomidate (not recommended for use in children less than 10 years and selectively inhibits 11 beta-hydroxylase)
- Patients who have a recognised indication for steroids
- Other immunosuppressive/immunomodulatory therapy (not including intravenous immunoglobulin which is considered standard therapy in toxic shock syndrome and may be given for this indication)
- Significant immunocompromise (eg HIV infection)
- Advanced malignancy
- Burns
- Cardiopulmonary resuscitation
- Children not likely to survive the time period of the maximum study intervention (5 days)
- Patients who have undergone organ transplantation (including bone marrow transplantation)
- Patients undergoing plasma exchange or whole blood exchange transfusion
- Treatment with an investigational drug or device within the last 30 days prior to enrolment.
- Patients who have experienced a prior episode of infection or sepsis during the current hospitalisation.
- Patients who are pregnant (a pregnancy test will be carried out for females of 11 years and above as is standard practice for clinical trials).
- Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00732277
Start Date
April 1 2008
End Date
April 1 2012
Last Update
May 6 2016
Active Locations (3)
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1
Bristol Royal Hospital for Children
Bristol, UK, United Kingdom, BS2 8BJ
2
Imperial College Healthcare NHS Trust
London, UK, United Kingdom, W2 1NY
3
Southampton University Hospitals NHS Trust
Southampton, UK, United Kingdom, SO16 6YD