脓毒症与危重病研究中心研究人员:危重症外科患者脓毒症前瞻性队列研究的方案与标准操作程序

Sepsis and Critical Illness Research Center investigators: protocols and standard operating procedures for a prospective cohort study of sepsis in critically ill surgical patients.

作者信息

Loftus Tyler J, Mira Juan C, Ozrazgat-Baslanti Tezcan, Ghita Gabriella L, Wang Zhongkai, Stortz Julie A, Brumback Babette A, Bihorac Azra, Segal Mark S, Anton Stephen D, Leeuwenburgh Christiaan, Mohr Alicia M, Efron Philip A, Moldawer Lyle L, Moore Frederick A, Brakenridge Scott C

机构信息

Department of Surgery, Sepsis and Critical Illness Research Center in Gainesville, University of Florida Health, Gainesville, Florida, USA.

Department of Surgery, University of Florida Health, Gainesville, Florida, USA.

出版信息

BMJ Open. 2017 Aug 1;7(7):e015136. doi: 10.1136/bmjopen-2016-015136.

Abstract

INTRODUCTION

Sepsis is a common, costly and morbid cause of critical illness in trauma and surgical patients. Ongoing advances in sepsis resuscitation and critical care support strategies have led to improved in-hospital mortality. However, these patients now survive to enter state of chronic critical illness (CCI), persistent low-grade organ dysfunction and poor long-term outcomes driven by the persistent inflammation, immunosuppression and catabolism syndrome (PICS). The Sepsis and Critical Illness Research Center (SCIRC) was created to provide a platform by which the prevalence and pathogenesis of CCI and PICS may be understood at a mechanistic level across multiple medical disciplines, leading to the development of novel management strategies and targeted therapies.

METHODS

Here, we describe the design, study cohort and standard operating procedures used in the prospective study of human sepsis at a level 1 trauma centre and tertiary care hospital providing care for over 2600 critically ill patients annually. These procedures include implementation of an automated sepsis surveillance initiative, augmentation of clinical decisions with a computerised sepsis protocol, strategies for direct exportation of quality-filtered data from the electronic medical record to a research database and robust long-term follow-up.

ETHICS AND DISSEMINATION

This study has been registered at ClinicalTrials.gov, approved by the University of Florida Institutional Review Board and is actively enrolling subjects. Dissemination of results is forthcoming.

摘要

引言

脓毒症是创伤和外科手术患者常见、代价高昂且导致发病的重症病因。脓毒症复苏及重症监护支持策略的不断进步已降低了院内死亡率。然而,这些患者如今存活下来进入了慢性重症疾病(CCI)状态,即由持续性炎症、免疫抑制和分解代谢综合征(PICS)导致的持续性轻度器官功能障碍及长期预后不良。脓毒症与重症疾病研究中心(SCIRC)的设立旨在提供一个平台,通过该平台可以从多个医学学科的机制层面理解CCI和PICS的患病率及发病机制,从而开发新的管理策略和靶向治疗方法。

方法

在此,我们描述了在一家一级创伤中心和三级护理医院对人类脓毒症进行前瞻性研究时所采用的设计、研究队列及标准操作程序,该医院每年为超过2600名重症患者提供护理。这些程序包括实施自动脓毒症监测计划、利用计算机化脓毒症方案强化临床决策、将经过质量筛选的数据从电子病历直接导出至研究数据库的策略以及完善的长期随访。

伦理与传播

本研究已在ClinicalTrials.gov注册,经佛罗里达大学机构审查委员会批准,目前正在积极招募受试者。研究结果即将公布。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a5e/5642775/a9bb52f2f42d/bmjopen-2016-015136f01.jpg

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