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Randomized Controlled Trial Multicenter Study
RESOLVE-ing sepsis in children--not yet!
- Simon Nadel.
- Paediatric Intensive Care, St Mary's Hospital and Imperial College, London W2 1NY, UK. s.nadel@imperial.ac.uk
- Crit Care. 2007 Jan 1; 11 (3): 138.
AbstractThe Researching Severe Sepsis and Organ Dysfunction in Children: A Global Perspective study of drotrecogin alpha activated versus placebo was the largest study of adjunctive therapy ever performed in children with severe sepsis. Despite this, the study failed to show any significant differences in outcome between the treatment and placebo groups. The results raise questions about how we should perform meaningful clinical trials in relatively rare conditions such as paediatric sepsis, where the easily measurable endpoints (such as death) are infrequent. A radical rethink of the design of such studies is urgently needed.
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