Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
复制标题
DOI：
10.1001/jama.2016.0289
复制
发表时间：
2016-02-23
期刊：
影响因子：
--
通讯作者：
Sepsis Definitions Task Force
中科院分区：
文献类型：
--
作者：
Shankar-Hari M;Phillips GS;Levy ML;Seymour CW;Liu VX;Deutschman CS;Angus DC;Rubenfeld GD;Singer M;Sepsis Definitions Task Force
脓毒性休克目前是指与感染相关的急性循环衰竭状态。新兴的生物学见解和流行病学的变化挑战了这一定义的有效性。为成人感染性休克的诊断提供新的定义和临床标准。重症监护医学会和欧洲重症监护医学会召集了一个工作组（19名参与者），以修订当前的脓毒症/脓毒性休克定义。进行了三组研究：（1）对1992年1月1日至2015年12月25日期间发表的成人观察性研究进行系统综述和荟萃分析，以确定目前报告的识别感染性休克的临床标准，并为德尔菲过程提供信息;（2）工作组的一项德尔菲研究，包括3项调查和对系统评价结果的讨论，和队列研究，以达成共识的一个新的脓毒性休克的定义和临床标准;和（3）队列研究，以测试变量确定的德尔菲过程中使用生存败血症运动（SSC）（2005-2010; n = 28 150）、匹兹堡大学医学中心（UPMC）（2010-2012; n = 1 309 025）和凯泽医疗北方加州（KPNC）（2009-2013; n = 1 847 165）电子健康记录（EHR）数据集。感染性休克定义和标准的证据和一致性。该系统性综述从总计92项脓毒症流行病学研究中确定了44项报告脓毒症休克结局的研究（总计166479例患者），这些研究报告了不同的血压（BP）、液体复苏、血管加压药、血清乳酸水平和碱缺乏的临界值和组合，以识别脓毒症休克。脓毒性休克相关的粗死亡率为46.5%（95%CI，42.7%-50.3%），研究间存在显著的统计异质性（I2 = 99.5%; τ2 = 182.5; P < .001）。德尔菲法将低血压、血清乳酸水平和血管加压药治疗作为变量，采用队列研究进行检验。基于这3个变量单独或组合，生成6个患者组。SSC数据库的检查表明，需要血管加压药以维持平均BP 65 mmHg或更高且血清乳酸水平大于2 mmol/L的患者组（18 mg/dL）的患者在液体复苏后的死亡率显著较高（42.3%[95%CI，41.2%-43.3%]），与其他5组进行风险调整后比较，使用血清乳酸水平单独大于2 mmol/L或低血压，血管加压药和血清乳酸水平2 mmol/L或更低。这些发现在UPMC和KPNC数据集中得到了验证。基于使用系统性综述、调查和队列研究结果的共识过程，脓毒性休克被定义为脓毒症的一个子集，其中潜在的循环、细胞和代谢异常与比单纯脓毒症更高的死亡风险相关。感染性休克成人患者可使用低血压的临床标准进行识别，需要血管加压治疗以维持平均BP 65 mmHg或更高，并且在充分液体复苏后血清乳酸水平大于2 mmol/L。
Septic shock currently refers to a state of acute circulatory failure associated with infection. Emerging biological insights and reported variation in epidemiology challenge the validity of this definition. To develop a new definition and clinical criteria for identifying septic shock in adults. The Society of Critical Care Medicine and the European Society of Intensive Care Medicine convened a task force (19 participants) to revise current sepsis/septic shock definitions. Three sets of studies were conducted: (1) a systematic review and meta-analysis of observational studies in adults published between January 1, 1992, and December 25, 2015, to determine clinical criteria currently reported to identify septic shock and inform the Delphi process; (2) a Delphi study among the task force comprising 3 surveys and discussions of results from the systematic review, surveys, and cohort studies to achieve consensus on a new septic shock definition and clinical criteria; and (3) cohort studies to test variables identified by the Delphi process using Surviving Sepsis Campaign (SSC) (2005–2010; n = 28 150), University of Pittsburgh Medical Center (UPMC) (2010–2012; n = 1 309 025), and Kaiser Permanente Northern California (KPNC) (2009–2013; n = 1 847 165) electronic health record (EHR) data sets. Evidence for and agreement on septic shock definitions and criteria. The systematic review identified 44 studies reporting septic shock outcomes (total of 166 479 patients) from a total of 92 sepsis epidemiology studies reporting different cutoffs and combinations for blood pressure (BP), fluid resuscitation, vasopressors, serum lactate level, and base deficit to identify septic shock. The septic shock–associated crude mortality was 46.5% (95%CI, 42.7%–50.3%), with significant between-study statistical heterogeneity (I2 = 99.5%; τ2 = 182.5; P < .001). The Delphi process identified hypotension, serum lactate level, and vasopressor therapy as variables to test using cohort studies. Based on these 3 variables alone or in combination, 6 patient groups were generated. Examination of the SSC database demonstrated that the patient group requiring vasopressors to maintain mean BP 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L (18 mg/dL) after fluid resuscitation had a significantly higher mortality (42.3%[95%CI, 41.2%–43.3%]) in risk-adjusted comparisons with the other 5 groups derived using either serum lactate level greater than 2 mmol/L alone or combinations of hypotension, vasopressors, and serum lactate level 2 mmol/L or lower. These findings were validated in the UPMC and KPNC data sets. Based on a consensus process using results from a systematic review, surveys, and cohort studies, septic shock is defined as a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone. Adult patients with septic shock can be identified using the clinical criteria of hypotension requiring vasopressor therapy to maintain mean BP 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L after adequate fluid resuscitation.