The Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), the sepsis performance measure introduced in 2015 by the Centers for Medicare & Medicaid Services (CMS), requires the reporting of up to 5 hemodynamic interventions, as many as 141 tasks, and 3 hours to document for a single patient.

To evaluate whether moderate- or high-level evidence shows that use of the 2015 SEP-1 or its hemodynamic interventions improves survival in adults with sepsis.

PubMed, Embase, Scopus, Web of Science, and ClinicalTrials.gov from inception to 28 November 2017 with no language restrictions.

Randomized and observational studies of death among adults with sepsis who received versus those who did not receive either the entire SEP-1 bundle or 1 or more SEP-1 hemodynamic interventions, including serial lactate measurements; a fluid infusion of 30 mL/kg of body weight; and assessment of volume status and tissue perfusion with a focused examination, bedside cardiovascular ultrasonography, or fluid responsiveness testing.

Two investigators independently extracted study data and assessed each study's risk of bias; 4 authors rated level of evidence by consensus using CMS criteria published in 2013. High- or moderate-level evidence required studies to have no confounders and low risk of bias.

Of 56 563 references, 20 studies (18 reports) met inclusion criteria. One single-center observational study reported lower in-hospital mortality after implementation of the SEP-1 bundle. Sixteen studies (2 randomized and 14 observational) reported increased survival with serial lactate measurements or 30-mL/kg fluid infusions. None of the 17 studies were free of confounders or at low risk of bias. In 3 randomized trials, fluid responsiveness testing did not alter survival.

Few trials, poor-quality and confounded studies, and no studies (with survival outcomes) of the focused examination or bedside cardiovascular ultrasonography. Use of the 2015 version of SEP-1 and 2013 version of CMS evidence criteria, both of which were updated in 2017.

No high- or moderate-level evidence shows that SEP-1 or its hemodynamic interventions improve survival in adults with sepsis.

National Institutes of Health. (PROSPERO: CRD42016052716)

严重败血症和败血性休克早期管理捆绑包 (SEP-1) 是医疗保险和医疗补助服务中心 (CMS) 于 2015 年推出的败血症绩效衡量标准，要求报告最多 5 项血流动力学干预措施、多达 141 项任务，为单个患者记录 3 小时。

评估中等或高水平证据表明使用 2015 SEP-1 或其血流动力学干预措施是否可以改善脓毒症成人患者的生存率。

PubMed、Embase、Scopus、Web of Science 和 ClinicalTrials.gov 从成立到 2017 年 11 月 28 日，没有语言限制。

对接受整套 SEP-1 治疗或未接受 1 次或多次 SEP-1 血流动力学干预（包括连续乳酸测量）的脓毒症成人患者的死亡进行随机观察研究；输液量为30毫升/公斤体重；通过重点检查、床边心血管超声检查或液体反应性测试来评估容量状态和组织灌注。

两名研究者独立提取研究数据并评估每项研究的偏倚风险； 4 位作者使用 2013 年发布的 CMS 标准对证据水平进行了共识评估。高或中等水平的证据要求研究没有混杂因素且偏倚风险低。

在 56 563 篇参考文献中，20 项研究（18 份报告）符合纳入标准。一项单中心观察性研究报告称，实施 SEP-1 捆绑后院内死亡率较低。 16 项研究（2 项随机研究和 14 项观察性研究）报告称，通过连续乳酸测量或 30 mL/kg 液体输注可提高生存率。这 17 项研究均不存在混杂因素或偏倚风险较低。在 3 项随机试验中，液体反应性测试并未改变生存率。

试验很少，研究质量差且混杂，并且没有针对重点检查或床边心血管超声检查的研究（具有生存结果）。使用2015年版SEP-1和2013年版CMS证据标准，两者均于2017年更新。

没有高水平或中等水平的证据表明 SEP-1 或其血流动力学干预措施可以改善脓毒症成人患者的生存率。

美国国立卫生研究院。 （普洛斯彼罗：CRD42016052716）