Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis - a Randomised Pilot Study
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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 recognition, powerful antibiotics, and good intensive care have improved
outcome, we need new ways to further reduce the number of deaths. Research in adults has
shown that steroid replacement therapy might be useful. However, children are known to
respond differently to adults and a definitive trial in children is needed because of the
potentially harmful as well as beneficial effects of steroids.
This pilot study will provide the necessary information to allow the rational design of a
large trial conducted at multiple hospitals investigating the role of corticosteroid
replacement therapy in childhood sepsis. The study will provide information on how to measure
the effects of steroids, information on length of therapy and a better understanding of how
steroids work in children. The results emerging from this study will ultimately allow
paediatric intensive care clinicians to know whether or not steroids are safe and/or useful.
The primary objective of this open-label study is therefore to gather clinical and laboratory
data with which to inform the design of a large phase 3 double blind randomised controlled
trial (RCT). The study will provide basic limited safety data, information on length of
therapy and an assessment of possible clinical and laboratory endpoints to be used in
addition to mortality.
Definition of sepsis:
Presence of a documented infection (eg clinical evidence of pneumonia, skin or soft tissue
infection, purpura fulminans, urinary tract infection, abdominal infection) or a diagnostic
positive blood culture (community or hospital acquired) within the last 72 hours and at least
two of the following, one of which must be abnormal temperature or leucocyte count[3] core
temperature of >38.5°C or <36°C; tachycardia (mean heart rate >2 SD above normal for age);
mean respiratory rate > 2 SD above normal for age; leucocyte count elevated or depressed for
age.
Definition of severe sepsis:
Sepsis plus cardiovascular organ dysfunction (the need for at least 5mcg/kg/min dopamine or
dobutamine, or any amount of adrenaline or noradrenaline support), acute respiratory distress
syndrome (ARDS), or 2 or more other organ dysfunctions.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborators:
Imperial College London St Mary's NHS Trust University Hospitals Bristol and Weston NHS Foundation Trust University Hospitals Bristol NHS Foundation Trust University of Bristol