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.
Highlights
The RESOLVE study failed to find any clear benefit for the use of drotrecogin alfa activated (DrotAA) in children with severe sepsis in the study population as a whole, or in any specific subgroup, either previously defined or after post-hoc analysis
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
This novel score, like many other scores introduced for the purposes of trial design, has been criticised for generating abstract numbers lacking clear clinical applicability, and for being substantially affected by early mortality events and differences in local management protocols for organ dysfunction resulting from such a widespread participation of recruiting centres [2]
Summary
The RESOLVE study failed to find any clear benefit for the use of DrotAA in children with severe sepsis in the study population as a whole, or in any specific subgroup, either previously defined or after post-hoc analysis. 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].
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