Chase Aaron, Almuntashiri Sultan, Sikora Andrea, Zhang Duo
Department of Pharmacy, Augusta University Medical Center, Augusta, GA.
Department of Clinical and Administrative Pharmacy, The University of Georgia College of Pharmacy, Augusta, GA.
Crit Care Explor. 2022 May 27;4(6):e0711. doi: 10.1097/CCE.0000000000000711. eCollection 2022 Jun.
Club cell secretory protein (CC16) is a protein with potential utility as a lung-specific biomarker for acute respiratory distress syndrome. The purpose of this study was to characterize CC16 in plasma from patients enrolled in the Fluid and Catheter Treatment Trial (FACTT) to determine the prognostic value for patient outcomes in our subgroup of FACTT patients.
A secondary biomarker analysis of a prospective randomized-controlled trial. The primary outcome was area under the receiver operating characteristic (AUROC) of CC16 for prediction of 90-day mortality. Secondary outcomes included differences in mortality, length of stay, and ventilator-free days (VFDs) between patients with high and low CC16. Statistical analyses were performed with IBM SPSS Statistics.
Single-center laboratory analysis.
Plasma samples from 68 FACTT subjects and 20 healthy controls.
CC16 was measured in patient plasma samples by enzyme-linked immunosorbent assay.
Subjects were an average of 48 years old (sd, 16.7 yr old) and 51.5% male. AUROC analysis of CC16 on day 1 showed an area under the ROC curve of 0.78 for prediction of mortality (odds ratio, 1.011; 95% CI, 1.003-1.021) with an optimal cutoff value of 45 ng/mL. Patients in the low CC16 group (<45 ng/mL) had lower mortality (7.5 vs 50.0%; < 0.001) and similar VFD (11.9 vs 13.2; = 0.638). When stratified by CC16 concentration, there was no difference between mortality in the fluid liberal (36.4 vs 58.8%; = 0.256) or conservative (4.3 vs 11.8%; = 0.366) groups.
CC16 demonstrated an acceptable AUROC for prediction of patient mortality with a cut point of 45 ng/mL. Patients with high CC16 on day 1 had worse outcomes compared with those with low CC16, suggesting a prognostic role for this lung-specific biomarker.
克拉拉细胞分泌蛋白（CC16）是一种具有潜在用途的蛋白质，可作为急性呼吸窘迫综合征的肺特异性生物标志物。本研究的目的是对参与液体与导管治疗试验（FACTT）的患者血浆中的CC16进行特征分析，以确定其在FACTT患者亚组中对患者预后的预测价值。
一项前瞻性随机对照试验的二次生物标志物分析。主要结局是CC16预测90天死亡率的受试者工作特征曲线下面积（AUROC）。次要结局包括CC16水平高和低的患者在死亡率、住院时间和无呼吸机天数（VFD）方面的差异。使用IBM SPSS Statistics进行统计分析。
单中心实验室分析。
68名FACTT受试者和20名健康对照者的血浆样本。
采用酶联免疫吸附测定法检测患者血浆样本中的CC16。
受试者平均年龄为48岁（标准差，16.7岁），男性占51.5%。第1天CC16的AUROC分析显示，预测死亡率的ROC曲线下面积为0.78（优势比，1.011；95%CI，1.003 - 1.021），最佳截断值为45 ng/mL。CC16水平低的组（<45 ng/mL）死亡率较低（7.5%对50.0%；<0.001），VFD相似（11.9对13.2；=0.638）。按CC16浓度分层时，液体宽松组（36.4%对58.8%；=0.256）或保守组（4.3%对11.8%；=0.366）的死亡率无差异。
CC16在预测患者死亡率方面显示出可接受的AUROC，截断点为45 ng/mL。第1天CC16水平高的患者与CC16水平低的患者相比结局更差，表明这种肺特异性生物标志物具有预后作用。
