Conclusions
A serum level of chemokine (C-C motif) ligand 4 of < or =140 pg/mL, when obtained within 24 hrs of admission, predicts a very high likelihood of survival in pediatric septic shock. Exclusion of patients with a chemokine (C-C motif) ligand 4 level of < or =140 pg/mL from interventional clinical trials in pediatric septic shock could create a study population in which survival benefit from the study agent could be more readily demonstrated.
Objective
Stratification with an effective outcome biomarker could improve the design of interventional trials in pediatric septic shock. The objective of this study was to test the usefulness of chemokine (C-C motif) ligand 4 as an outcome biomarker for mortality in pediatric septic shock. Design: A cross-sectional, observational study. Setting: Eighteen pediatric intensive care units in the United States. Patients: One hundred fifty-six pediatric patients with septic shock. Interventions: Serum samples were obtained within 24 hrs of admission to the pediatric intensive care unit. Serum levels of chemokine (C-C motif) ligand 4 were measured by enzyme-linked immunosorbent assay and compared with mortality in a training set of 34 patients. These data were used to generate a cutoff value whose usefulness was evaluated through prospective application-without post hoc modification-to a larger validation set of 122 patients. Measurements and main
Results
On inspection of the training set data, a cutoff value of 140 pg/mL was chosen. When applied to the validation set, serum chemokine (C-C motif) ligand 4 levels >140 pg/mL yielded a sensitivity of 92% and a specificity of 40% for mortality. A serum level of < or =140 pg/mL had a negative predictive value for mortality of 98%. Conclusions: A serum level of chemokine (C-C motif) ligand 4 of < or =140 pg/mL, when obtained within 24 hrs of admission, predicts a very high likelihood of survival in pediatric septic shock. Exclusion of patients with a chemokine (C-C motif) ligand 4 level of < or =140 pg/mL from interventional clinical trials in pediatric septic shock could create a study population in which survival benefit from the study agent could be more readily demonstrated.
