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Báo cáo khoa học: "RESOLVE-ing sepsis in children – not yet"
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Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care giúp cho các bạn có thêm kiến thức về ngành y học đề tài: RESOLVE-ing sepsis in children – not yet! | Available online http ccforum.eom content 11 3 138 Commentary RESOLVE-ing sepsis in children - not yet Simon Nadel Paediatric Intensive Care St Mary s Hospital and Imperial College London W2 1NY UK Corresponding author Simon Nadel s.nadel@imperial.ac.uk Published 8 June 2007 Critical Care 2007 11 138 doi 10.1186 cc5919 This article is online at http ccforum.com content 11 3 138 2007 BioMed Central Ltd Abstract The Researching Severe Sepsis and Organ Dysfunction in Children A Global Perspective study of drotrecogin alfa 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. The efficacy and safety of drotrecogin alfa activated DrotAA recombinant human activated protein C was assessed in children with severe sepsis in the Researching Severe Sepsis and Organ Dysfunction in Children A Global Perspective RESOLVE study 1 . In this double-blind randomised placebo-controlled multicentre multinational trial 477 patients were enrolled at 104 study sites. Children with severe sepsis were randomly assigned to a 4day course of DrotAA or placebo. The primary endpoint was a novel score the composite time to complete organ failure resolution. Secondary endpoints were the all-cause mortality up to 28 days after treatment and safety. The primary endpoint was derived in an attempt to determine clinically useful endpoints of morbidity which both clinicians and patients and their families would view as a tangible outcome including cessation of vasopressor therapy extubation and cessation of renal replacement therapy . This novel score .