背景:脓毒症是一种常见且致命的综合征,每年超过1100万人死亡。为了更深入地了解导致败血症不良结局的宿主和病原体机制,从而可能告知新的治疗目标,复杂的,通常需要昂贵的生物储存库。我们建议残余生物标本是机械性败血症研究的替代方法,尽管这些残留物的可行性和科学价值尚不清楚。
结果:败血症研究中的残余生物样本调查是一项前瞻性队列研究,对225名成年人(年龄≥18岁)因社区败血症而到急诊科就诊,定义为在到达后6小时内的脓毒症-3标准。主要目的是确定与电子健康记录中的临床表型相关的败血症中残留生物标本库的科学价值。我们将研究脓毒症生物学的候选多体读数,受概念模型支配,并确定精度,准确度,完整性,和蛋白质的可比性,小分子,脂质,与根据研究方案获得的成对生物标本相比,残余生物标本中的病原体测序。配对的生物标本将包括来自肝素钠的血浆,EDTA,氟化钠,和柠檬酸管。
结论:该研究已获得匹兹堡大学人类研究保护办公室的批准(研究21120013)。招聘于2022年10月25日开始,计划于2024年发布主要结果。结果将向公众公布,资助者,重症监护协会,实验室医学科学家,和其他研究人员。
BACKGROUND: Sepsis is a common and deadly syndrome, accounting for more than 11 million deaths annually. To mature a deeper understanding of the host and pathogen mechanisms contributing to poor outcomes in sepsis, and thereby possibly inform new therapeutic targets, sophisticated, and expensive biorepositories are typically required. We propose that remnant biospecimens are an alternative for mechanistic sepsis research, although the viability and scientific value of such remnants are unknown.
RESULTS: The Remnant
Biospecimen Investigation in Sepsis study is a prospective cohort study of 225 adults (age ≥ 18 yr) presenting to the emergency department with community sepsis, defined as sepsis-3 criteria within 6 hours of arrival. The primary objective was to determine the scientific value of a remnant
biospecimen repository in sepsis linked to clinical phenotyping in the electronic health record. We will study candidate multiomic readouts of sepsis biology, governed by a conceptual model, and determine the precision, accuracy, integrity, and comparability of proteins, small molecules, lipids, and pathogen sequencing in remnant biospecimens compared with paired biospecimens obtained according to research protocols. Paired biospecimens will include plasma from sodium-heparin, EDTA, sodium fluoride, and citrate tubes.
CONCLUSIONS: The study has received approval from the University of Pittsburgh Human Research Protection Office (Study 21120013). Recruitment began on October 25, 2022, with planned release of primary results anticipated in 2024. Results will be made available to the public, the funders, critical care societies, laboratory medicine scientists, and other researchers.