Division of Critical Care Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Pediatr Crit Care Med. 2010 Mar;11(2):213-6. doi: 10.1097/PCC.0b013e3181b8076c.
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.
A cross-sectional, observational study.
Eighteen pediatric intensive care units in the United States.
One hundred fifty-six pediatric patients with septic shock.
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.
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%.
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.
通过使用有效的疗效生物标志物进行分层，可以改善儿科脓毒性休克介入性试验的设计。本研究的目的是检验趋化因子（C-C 基序）配体 4 作为儿科脓毒性休克死亡率的疗效生物标志物的作用。
横断面观察性研究。
美国 18 个儿科重症监护病房。
156 例脓毒性休克的儿科患者。
在入住儿科重症监护病房的 24 小时内获得血清样本。通过酶联免疫吸附试验测量趋化因子（C-C 基序）配体 4 的血清水平，并与 34 例患者的训练集中的死亡率进行比较。使用这些数据生成一个截止值，然后通过前瞻性应用（无事后修改）到更大的 122 例验证集中，来评估其有效性。
在检查训练集数据时，选择 140pg/ml 作为截止值。当应用于验证集时，血清趋化因子（C-C 基序）配体 4 水平>140pg/ml 对死亡率的敏感性为 92%，特异性为 40%。血清水平<或=140pg/ml 对死亡率的阴性预测值为 98%。
在入住后 24 小时内获得的趋化因子（C-C 基序）配体 4 的血清水平<或=140pg/ml 可预测儿科脓毒性休克患者的生存可能性非常高。将趋化因子（C-C 基序）配体 4 水平<或=140pg/ml 的患者排除在儿科脓毒性休克的介入性临床试验之外，可以创建一个研究人群，更容易证明研究药物的生存获益。
