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

Interventional clinical trials involving children with septic shock would benefit from an efficient preenrollment stratification strategy. To test the predictive value of interleukin (IL)-8 for 28-day mortality in pediatric septic shock. A training data set (n = 40) identified a serum IL-8 of greate...

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Bibliographic Details
Published in:American journal of respiratory and critical care medicine 2008-08, Vol.178 (3), p.276-282
Main Authors: Wong, Hector R, Cvijanovich, Natalie, Wheeler, Derek S, Bigham, Michael T, Monaco, Marie, Odoms, Kelli, Macias, William L, Williams, Mark D
Format: Article
Language:English
Subjects:
Biomarkers
Biomarkers - blood
Child
Child, Preschool
Clinical trials
Cytokines
D. Critical Care
Databases, Factual
Datasets
Enrollments
Female
Genomics
Humans
Hypotheses
Infant
Interleukin-8 - blood
Male
Mortality
Patients
Pediatrics
Predictive Value of Tests
ROC Curve
Sepsis
Severity of Illness Index
Shock, Septic - blood
Shock, Septic - physiopathology
Survival Analysis
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Summary:Interventional clinical trials involving children with septic shock would benefit from an efficient preenrollment stratification strategy. To test the predictive value of interleukin (IL)-8 for 28-day mortality in pediatric septic shock. 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. 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. 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.
ISSN:1073-449X
1535-4970
DOI:10.1164/rccm.200801-131OC