Arora Jaskirat, Klowak Jennifer A, Parpia Sameer, Zapata-Canivilo Marcelo, Faidi Walaa, Skappak Christopher, Gregoris Rachael, Kretz Colin A, Dwivedi Dhruva J, de Wit Kerstin, Welsford Michelle, Fox-Robichaud Alison
Thrombosis & Atherosclerosis Research Institute (TaARI), Department of Medicine, McMaster University, Hamilton, ON, Canada.
Department of Pediatrics, McMaster Children's Hospital, Hamilton, ON, Canada.
Crit Care Explor. 2021 Apr 26;3(4):e0414. doi: 10.1097/CCE.0000000000000414. eCollection 2021 Apr.
Between 75% and 80% of patients with sepsis arrive in the hospital through the emergency department. Early diagnosis is important to alter patient prognosis, but currently, there is no reliable biomarker. The innate immune response links inflammation and coagulation. Several coagulation -related biomarkers are associated with poor prognosis in the ICU. The role of coagulation biomarkers to aid in early sepsis diagnosis has not previously been investigated. The objective of our study is to determine the individual or combined accuracy of coagulation and inflammation biomarkers with standard biochemical tests to diagnose adult septic patients presenting to the emergency department.
in the Emergency Department is a prospective, observational cohort study with a target enrolment of 250 suspected septic patients from two Canadian emergency departments. The emergency physicians will enroll patients with suspected sepsis. Blood samples will be collected at two time points (initial presentation and 4 hr following). Patients will be adjudicated into septic, infected, or not infected status in accordance with the Sepsis-3 definitions. Patient demographics, cultures, diagnosis, and biomarkers will be reported using descriptive statistics. Optimal cut off values with sensitivity and specificity for each biomarker will be determined using C-statistics to distinguish between septic and nonseptic patients. Stepwise multiple logistic regression analysis with exclusion of nonsignificant covariates from the final model will be used to establish a panel of biomarkers.
Our protocol describes the processes and methods for a pragmatic observational biomarker study in the emergency department. This study will seek to determine the potential diagnostic importance of early coagulation abnormalities to identify additional tools for sepsis diagnosis.
75%至80%的脓毒症患者通过急诊科入院。早期诊断对于改变患者预后很重要，但目前尚无可靠的生物标志物。固有免疫反应将炎症与凝血联系起来。几种与凝血相关的生物标志物与重症监护病房（ICU）的不良预后相关。此前尚未研究过凝血生物标志物在脓毒症早期诊断中的作用。我们研究的目的是确定凝血和炎症生物标志物与标准生化检测相结合用于诊断急诊科成年脓毒症患者的个体或综合准确性。
“急诊科研究”是一项前瞻性观察性队列研究，目标是从两个加拿大急诊科招募250名疑似脓毒症患者。急诊医生将招募疑似脓毒症患者。在两个时间点（初次就诊时和之后4小时）采集血样。将根据脓毒症-3定义将患者判定为脓毒症、感染或未感染状态。将使用描述性统计报告患者的人口统计学、培养结果、诊断和生物标志物。将使用C统计量确定每个生物标志物的具有敏感性和特异性的最佳临界值，以区分脓毒症患者和非脓毒症患者。将使用逐步多元逻辑回归分析，从最终模型中排除无显著意义的协变量，以建立一组生物标志物。
我们的方案描述了急诊科一项实用的观察性生物标志物研究的过程和方法。本研究将试图确定早期凝血异常的潜在诊断重要性，以识别脓毒症诊断的其他工具。
