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Early Goal-Directed Therapy in the Management of Severe Sepsis Or Zhang et al. BMC Medicine (2015) 13:71 DOI 10.1186/s12916-015-0312-9 RESEARCH ARTICLE Open Access Early goal-directed therapy in the management of severe sepsis or septic shock in adults: a meta-analysis of randomized controlled trials Ling Zhang1, Guijun Zhu2, Li Han3 and Ping Fu4* Abstract Background: The Surviving Sepsis Campaign guidelines have proposed early goal-directed therapy (EGDT) as a key strategy to decrease mortality among patients with severe sepsis or septic shock. However, its effectiveness is uncertain. Methods: We searched for relevant studies in Medline, Embase, the Cochrane Library, Google Scholar, and a Chinese database (SinoMed), as well as relevant references from January 1966 to October 2014. We performed a systematic review and meta-analysis of all eligible randomized controlled trials (RCTs) of EGDT for patients with severe sepsis or septic shock. The primary outcome was mortality; secondary outcomes were length of ICU and in-hospital stay, mechanical ventilation support, vasopressor and inotropic agents support, fluid administration, and red cell transfusion. We pooled relative risks (RRs) or weighted mean differences (MDs) with 95% confidence intervals (95% CI) using Review Manager 5.2. Results: We included 10 RCTs from 2001 to 2014 involving 4,157 patients. Pooled analyses of all studies showed no significant difference in mortality between the EGDT and the control group (RR 0.91, 95% CI: 0.79 to 1.04, P = 0.17), with substantial heterogeneity (χ2 = 23.65, I2 = 58%). In the subgroup analysis, standard EGDT, but not modified EGDT, was associated with lower mortality rate in comparison with the usual care group (RR 0.84, 95% CI: 0.72 to 0.98, P = 0.03). However, EGDT was associated with a higher mortality rate in comparison with the early lactate clearance group (RR 1.52, 95% CI: 1.06 to 2.18, P = 0.02). In the first 6 h, compared with usual care, patients in EGDT received more inotropic agents (P = 0.04), fluid administration (P = 0.05), and red cell transfusion (P <0.01). There were no significant differences in length of ICU stay (P = 0.73) or in-hospital stay (P = 0.57), ventilation rate (P = 0.53), and vasopressor support (P =0.63). Conclusions: EGDT was not associated with a survival benefit among patients with severe sepsis or septic shock. Instead, EGDT was associated with a higher mortality rate in comparison to the early lactate clearance group. Further high-quality RCTs comparing EGDT with early lactate clearance are desirable. Keywords: EGDT, Early goal-directed, Resuscitation, Sepsis, Meta-analysis Background 50% [1-3]. In 2001, Rivers et al. first reported that a spe- Severe sepsis and septic shock are common complica- cific 6-h protocol of early goal-directed therapy (EGDT) tions of patients with critical illness, with an annual inci- significantly reduced the mortality rate of patients with dence of up to 300 cases per 100,000 people in the severe sepsis and septic shock presenting to the emer- United States [1]. Despite efforts to improve its manage- gency department, as compared with the usual therapy ment, sepsis remains the 10th leading cause of death in [4]. EGDT was subsequently incorporated into the 6-h the United States, with an associated mortality of 20% to resuscitation bundle of the Surviving Sepsis Campaign guidelines [5-7], and many studies showed a survival benefit with EGDT or a sepsis bundle including EGDT * Correspondence: [email protected] 4Division of Nephrology, West China Hospital of Sichuan University, [8-12]. However, in 2014, two multicenter randomized Chengdu, Sichuan, China controlled trials (RCTs) showed that EGDT was not Full list of author information is available at the end of the article © 2015 Zhang et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Zhang et al. BMC Medicine (2015) 13:71 Page 2 of 12 associated with a survival benefit in comparison with Search methods for identification of studies usual care [13,14]. A recent cohort study showed that Study selection EGDT might increase the risk of fluid overload and mor- We used the Cochrane risk of bias tool [17] to under- tality [15]. Thus, we sought to systematically review the take, and the PRISMA (Preferred Reporting Items for current literature and to analyze all studies implement- Systematic Reviews and Meta-Analyses) statement meth- ing EGDT for the management of patients with severe odology [18] to report, a systematic review and meta- sepsis or septic shock. analysis of RCTs. Two independent reviewers (LZ and GZ) conducted a search in PubMed, Embase, the Cochrane Li- brary, Google Scholar, a Chinese database (SinoMed), and Materials and methods major critical care medicine journals. Trials were consid- We performed this systematic review using the guide- ered without language or date restriction. We performed lines proposed by the Cochrane Collaboration in the the last updated search on 5 October 2014. The following Cochrane Handbook for Systematic Reviews of Interven- text words and corresponding heading terms were used as tions [16]. There was no registered protocol. search terms: “sepsis or septic shock” and “EGDT or early goal directed or goal directed or goal oriented or goal tar- get or sepsis bundle or hemodynamic optimization or Study selection criteria protocol or program or procedure”. The exact search Participants strategy was provided in Appendix 1. Related articles This review focused on patients with severe sepsis or and reference lists were manually searched to avoid septic shock who received EGDT or a sepsis bundle in- omissions. After title screening, we evaluated abstracts cluding EGDT. for relevance and identified them as included, excluded, or requiring further assessment. At this stage, if a paper Interventions required further assessment, we contacted the study For the purpose of the review, we use the term “EGDT” lead investigator by e-mail and/or telephone with a re- to describe standard EGDT, modified EGDT, or a sepsis quest for further information. bundle based on standard EGDT, with details presented in Table 1. Standard EGDT was described as a 6-h Data extraction protocol resuscitation conforming to specific therapeutic targets of central venous pressure (CVP) between 8 and The inclusion criteria were as follows: (a) sepsis patients 12 mm Hg, mean arterial pressure (MAP) between 65 with hypotension (systolic blood pressure of less than and 90 mm Hg, urine output 0.5 ml/kg/h or more, and 90 mm Hg or a mean arterial pressure of less than continuous monitoring to keep central venous oxygen 65 mm Hg) or hypoperfusion (blood lactate level of 4.0 mmol per liter or more); and (b) studies comparing saturation (ScvO2) at 70% or above [4]. We defined modified EGDT as a similar or simplified 6-h protocol EGDT with usual care or other intervention, and (c) suf- based on standard EGDT [4]. The intervention of the ficient data available to calculate a relative risk (RR) or control group was usual care or other strategies de- mean difference (MD) with 95% confidence interval scribed in original studies. (95% CI). The following exclusion criteria were used: (a) EGDT was performed in all patients or studies of com- pliance with EGDT; and (b) EGDT not based on pub- Types of outcome measures lished protocol [4]; and (c) pediatric patients; and (d) The primary outcomes were mortality among patients nonhuman studies. For studies with the same or overlap- with severe sepsis or septic shock. Length of ICU and ping data by the same authors, the most suitable studies in-hospital stay, mechanical ventilation support, vaso- with the largest number of cases or latest publication pressor and inotropic agents support, fluid administra- dates were selected. tion and red cell transfusion rate in the first 6 h were Two investigators (LZ and GZ) assessed each trial in- also analyzed. dependently and recorded eligibility, quality, and out- comes. Disagreements regarding eligibility arose with 7% of the articles (κ = 0.87), which were resolved by a third Types of studies party through consensus. A third investigator (FP) pro- We included all RCTs comparing EGDT with usual care vided arbitration in case of disagreement. We extracted or other strategies for patients with severe sepsis or sep- the following study features: first author, publication tic shock. We excluded non-randomized studies, studies year, country, number of participants, protocol of EGDT, published in abstracts, reviews, commentaries, and mortality, length of ICU and in-hospital stay, ventilation editorials. rate, vasopressor support, inotropic agents support, and Zhang et al. BMC Medicine (2015) 13:71 Page 3 of 12 Table 1 EGDT protocol and outcome of selected trials Study EGDT group Control group Survival benefit Standard EGDT versus usual care ARISE 2014 [13] ScvO2 ≥ 70% Usual care No: 28d/90d/ICU/in-hospital mortality CVP ≥ 8-12 mm Hg MAP ≥ 65 mm Hg UO ≥ 0.5 ml/kg/h Jing 2010 [8] ScvO2 ≥ 70% CVP ≥ 8-12 mm Hg Yes: 28d/ICU mortality CVP ≥ 8-12 mm Hg SBP > 100 mm Hg SBP >100 mm Hg MAP ≥ 65 mm Hg MAP ≥ 65 mm Hg UO ≥ 0.5 ml/kg/h UO ≥ 0.5 ml/kg/h ProCESS 2014 [14] ScvO2 ≥ 70% Usual care No: 60d/in-hospital
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