Interleukin-8 as a stratification tool for interventional trials involving pediatric septic shock

Hector R. Wong, Natalie Cvijanovich, Derek S. Wheeler, Michael T. Bigham, Marie Monaco, Kelli Odoms, William L. Macias, Mark D. Williams

Research output: Contribution to journalArticlepeer-review

101 Scopus citations

Abstract

Rationale: Interventional clinical trials involving children with septic shock would benefit from an efficient preenrollment stratification strategy. Objectives: To test the predictive value of interleukin (IL)-8 for 28-day mortality in pediatric septic shock. Methods: 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. Measurements and Main Results: Subjects were drawn from two large, independent pediatric septic shock databases. Prospective application of the IL-8 cut off to validation data set 1 (n=139) demonstrated 78% sensitivity and 64% specificity for 28-day mortality.Aserum 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)276-282
Number of pages7
JournalAmerican journal of respiratory and critical care medicine
Volume178
Issue number3
DOIs
StatePublished - Aug 1 2008
Externally publishedYes

Keywords

  • Biomarkers
  • Interleukin-8
  • Pediatrics
  • Septic shock
  • Stratification

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

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