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Published ahead of print on May 29, 2008, doi:10.1164/rccm.200801-131OC

Am. J. Respir. Crit. Care Med., Volume 178, Number 3, August 2008, 276-282

A more recent version of this article appeared on August 1, 2008
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Submitted on January 21, 2008
Accepted on May 29, 2008

Interleukin-8 as a Stratification Tool for Interventional Trials Involving Pediatric Septic Shock

Hector R Wong1*, Natalie Cvijanovich2, Derek S Wheeler1, Michael T Bigham1, Marie Monaco1, Kelli Odoms1, William L Macias3, and Mark D Williams3

1 Division of Critical Care Medicine, Cincinnati Chilren's Hosptial Medical Center and Cincinnati Children's Research Foundation, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA, 2 Division of Critical Care Medicine, Children's Hospital and Research Center Oakland, Oakland, CA, USA, 3 Eli Lilly Research Laboratories, Indianapolis, IN, USA

* To whom correspondence should be addressed. E-mail: hector.wong{at}cchmc.org.

Rationale: Interventional clinical trials involving children with septic shock would benefit from an efficient pre-enrollment stratification strategy. Objective: To test the predictive value of interleukin-8 (IL-8) for 28 day mortality in pediatric septic shock. Methods: A training data set (n = 40) identified a serum IL-8 > 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. Measurements and Main Results: 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 ≤ 220 pg/ml, 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 ≤ 220 pg/ml had a negative predictive value for 28 day mortality of 94% when applied to validation set #2. Conclusion: A serum IL-8 level ≤ 220 pg/ml, 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.
Key words: Pediatrics, septic shock, biomarkers, interleukin-8, stratification




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