Aletti Federico, Conti Costanza, Ferrario Manuela, Ribas Vicent, Bollen Pinto Bernardo, Herpain Antoine, Post Emiel, Romay Medina Eduardo, Barlassina Cristina, de Oliveira Eliandre, Pastorelli Roberta, Tedeschi Gabriella, Ristagno Giuseppe, Taccone Fabio S, Schmid-Schönbein Geert W, Ferrer Ricard, De Backer Daniel, Bendjelid Karim, Baselli Giuseppe
Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano - Piazza Leonardo da Vinci, 32-20133, Milan, Italy.
Custom Software & Electronics SL, Barcelona, Spain.
Scand J Trauma Resusc Emerg Med. 2016 Jan 28;24:9. doi: 10.1186/s13049-016-0197-4.
The ShockOmics study (ClinicalTrials.gov identifier NCT02141607) is a multicenter prospective observational trial aimed at identifying new biomarkers of acute heart failure in circulatory shock, by means of a multiscale analysis of blood samples and hemodynamic data from subjects with circulatory shock.
Ninety septic shock and cardiogenic shock patients will be recruited in three intensive care units (ICU) (Hôpital Erasme, Université Libre de Bruxelles, Belgium; Hospital Universitari Mutua Terrassa, Spain; Hôpitaux Universitaires de Genève, Switzerland). Hemodynamic signals will be recorded every day for up to seven days from shock diagnosis (time T0). Clinical data and blood samples will be collected for analysis at: i) T1 < 16 h from T0; ii) T2 = 48 h after T0; iii) T3 = day 7 or before discharge or before discontinuation of therapy in case of fatal outcome; iv) T4 = day 100. The inclusion criteria are: shock, Sequential Organ Failure Assessment (SOFA) score > 5 and lactate levels ≥ 2 mmol/L. The exclusion criteria are: expected death within 24 h since ICU admission; > 4 units of red blood cells or >1 fresh frozen plasma transfused; active hematological malignancy; metastatic cancer; chronic immunodepression; pre-existing end stage renal disease requiring renal replacement therapy; recent cardiac surgery; Child-Pugh C cirrhosis; terminal illness. Enrollment will be preceded by the signature of the Informed Consent by the patient or his/her relatives and by the physician in charge. Three non-shock control groups will be included in the study: a) healthy blood donors (n = 5); b) septic patients (n = 10); c) acute myocardial infarction or patients with prolonged acute arrhythmia (n = 10). The hemodynamic data will be downloaded from the ICU monitors by means of dedicated software. The blood samples will be utilized for transcriptomics, proteomics and metabolomics ("-omics") analyses.
ShockOmics will provide new insights into the pathophysiological mechanisms underlying shock as well as new biomarkers for the timely diagnosis of cardiac dysfunction in shock and quantitative indices for assisting the therapeutic management of shock patients.
休克组学研究（ClinicalTrials.gov标识符NCT02141607）是一项多中心前瞻性观察性试验，旨在通过对循环性休克患者的血样和血流动力学数据进行多尺度分析，确定循环性休克中急性心力衰竭的新生物标志物。
将在三个重症监护病房（ICU）（比利时布鲁塞尔自由大学伊拉斯谟医院；西班牙特拉萨大学医院互助医院；瑞士日内瓦大学医院）招募90名感染性休克和心源性休克患者。从休克诊断（时间T0）起，每天记录血流动力学信号，最长记录7天。将在以下时间点收集临床数据和血样进行分析：i）T1＜T0后16小时；ii）T2 = T0后48小时；iii）T3 = 第7天或出院前或在出现致命结局时停止治疗前；iv）T4 = 第100天。纳入标准为：休克、序贯器官衰竭评估（SOFA）评分＞5且乳酸水平≥2 mmol/L。排除标准为：预计自入住ICU起24小时内死亡；输注超过4单位红细胞或超过1单位新鲜冰冻血浆；活动性血液系统恶性肿瘤；转移性癌症；慢性免疫抑制；既往存在需要肾脏替代治疗的终末期肾病；近期心脏手术；Child-Pugh C级肝硬化；晚期疾病。在招募患者之前，患者或其亲属以及主管医生需签署知情同意书。研究将纳入三个非休克对照组：a）健康献血者（n = 5）；b）脓毒症患者（n = 10）；c）急性心肌梗死或急性心律失常持续时间较长的患者（n = 10）。血流动力学数据将通过专用软件从ICU监护仪下载。血样将用于转录组学、蛋白质组学和代谢组学（“组学”）分析。
休克组学将为休克潜在的病理生理机制提供新的见解，以及为休克时心脏功能障碍的及时诊断提供新的生物标志物和协助休克患者治疗管理的定量指标。
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