Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis - a Randomised Pilot Study

Launched by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST · Aug 8, 2008

Keywords

ClinConnect Summary

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 have been of benefit in children. The results of adult studies cannot therefore be extrapolated directly to childhood disease. Corticosteroids alter the inflammatory balance in both beneficial and harmful ways in severe sepsis. Recent adult studies have demonstrated transient adrenal insufficiency is associated with adverse outcome and that corticosteroids increase survival in specific patient gro...

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.