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- Title
Interleukin-8 as a stratification tool for interventional trials involving pediatric septic shock.
- Authors
Wong HR; Cvijanovich N; Wheeler DS; Bigham MT; Monaco M; Odoms K; Macias WL; Williams MD; Wong, Hector R; Cvijanovich, Natalie; Wheeler, Derek S; Bigham, Michael T; Monaco, Marie; Odoms, Kelli; Macias, William L; Williams, Mark D
- Abstract
<bold>Rationale: </bold>Interventional clinical trials involving children with septic shock would benefit from an efficient preenrollment stratification strategy.<bold>Objectives: </bold>To test the predictive value of interleukin (IL)-8 for 28-day mortality in pediatric septic shock.<bold>Methods: </bold>A training data set (n = 40) identified a serum IL-8 of greater than 220 pg/ml as having a 75% sensitivity and specificity for predicting 28-day mortality. This cutoff was then subjected to a series of validation steps.<bold>Measurements and Main Results: </bold>Subjects were drawn from two large, independent pediatric septic shock databases. Prospective application of the IL-8 cutoff to validation data set 1 (n = 139) demonstrated 78% sensitivity and 64% specificity for 28-day mortality. A serum IL-8 level of 220 pg/ml or less, however, had a negative predictive value for 28-day mortality of 95% in validation data set 1, which was subsequently applied to an independently generated data set of children with septic shock (validation set 2, n = 193). A serum IL-8 level of 220 pg/ml or less had a negative predictive value for 28-day mortality of 94% when applied to validation set 2.<bold>Conclusions: </bold>A serum IL-8 level of 220 pg/ml or less, obtained within 24 hours of admission, predicts a high likelihood of survival in children with septic shock. We propose that IL-8 can be used to exclude such patients from interventional clinical trials and ultimately derive a study population with a more favorable risk to benefit ratio when subjected to a study agent.
- Publication
American Journal of Respiratory & Critical Care Medicine, 2008, Vol 178, Issue 3, p276
- ISSN
1073-449X
- Publication type
journal article
- DOI
10.1164/rccm.200801-131OC