- Participating institutions: St Mary’s Hospital, London, UK, University of Southampton, Southampton, UK, Bristol University, Bristol, UK
- Researchers: Anabelle Smale, Dr John Pappachan, Dr Sarah Walker, Prof Saul Faust, Dr Simon Nadel, Helen Cracknell, Lucy Grace, Prof Andrew Wolf, Prof Diana Gibb, Prof Mike Levin, Prof Rob Heyderman
- Start date: 1 January 2007
This project is an open randomised prospective pilot exploratory clinical trial of corticosteroid replacement therapy in paediatric sepsis (including meningococcal sepsis) to be carried out in three major UK Paediatric Intensive Care Units. Adrenal function, inflammatory and coagulation profiles will be assessed before, during and after low-dose corticosteroid replacement therapy using a 2-stage approach. Despite adult studies, the clinical and immunological basis for corticosteroid therapy in paediatric sepsis is not established, and this work is essential to the design and safety of a large phase 3 study in paediatric intensive care. Severe sepsis has a considerable impact on childhood mortality, UK healthcare services and the public health in general. Targeted use of existing or novel adjunctive therapies to improve outcome is therefore required. Experimental therapies should not be introduced into paediatric practice without clear evidence of possible clinical benefit and safety. This study is an important first step in the provision of an evidence base for the rational use of steroids in paediatric sepsis, thus avoiding ad-hoc inappropriate use.
Using data generated in this pilot study, we intend to move rapidly to design a large randomised controlled trial conducted at multiple hospitals investigating the role of corticosteroid replacement therapy in childhood sepsis, seeking additional funding support from other sources and involving the National Medicines for Children Research Network (MCRN) and international collaborators. This 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 understand the safety and efficacy of corticosteroid use in sepsis.