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Early, Goal-Directed Therapy for Septic Shock — A Patient-Level Meta-Analysis

N Engl J Med 2017; 377:994-995

DOI: 10.1056/NEJMc1708979

To the Editor: 致编辑

In reporting the results of their meta-analysis of individual patient data from three trials, the Protocolized Resuscitation in Sepsis Meta-Analysis (PRISM) investigators (June 8 issue)1 conclude that early, goal-directed therapy (EGDT) did not result in better outcomes than usual care in the resuscitation of patients with septic shock. I was hoping that the meta-analysis would answer an important question — what is usual care? EGDT is a well-defined intervention to guide hemodynamic resuscitation according to targets for central venous pressure, mean arterial blood pressure, urinary output, and central venous oxygen saturation.


Which monitoring tools and hemodynamic targets (other than central venous pressure, mean arterial blood pressure, and urinary output) were used by the physicians in the usual-care groups in the three trials to guide their decision to administer or withhold fluids, vasopressors, and blood products? Such data are very important to guide recommendations for therapy, as well as to clarify how usual care was associated with a significant increase in the rate of serious adverse events as compared with EGDT in the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial2 (1.8% vs. 0.5%; absolute risk difference, 1.3 percentage points; 95% confidence interval, 0.18 to 2.54; P=0.03; number needed to harm [i.e., the number of patients needed for one adverse event to occur], 76.9).

在3项临床试验的常规治疗组中,临床医生采用什么监测手段及血流动力学目标(除中心静脉压、平均动脉压和尿量外)治疗液体治疗、升压药物及血液制品使用的决策?这些数据对于指导治疗非常重要,同时对于理解ARISE研究中常规治疗组较EGDT组严重不良事件显著增加也至关重要(1.8% vs. 0.5%; 绝对风险差异, 1.3%; 95%可信区间, 0.18 to 2.54; P=0.03; 造成危害需病例数 [即,一个不良事件发生所需患者数], 76.9)。

Ahmad S. Saleh, M.B., B.Ch., M.Sc.

Okba Ben Nafee Hospital, Alexandria, Egypt

No potential conflict of interest relevant to this letter was reported.


1. The PRISM Investigators. Early, goal-directed therapy for septic shock — a patient-level meta-analysis. N Engl J Med 2017;376:2223-2234 Full Text | Web of Science | Medline

2. The ARISE Investigators and the ANZICS Clinical Trials Group. Goal-directed resuscitation for patients with early septic shock. N Engl J Med 2014;371:1496-1506 Free Full Text | Web of Science | Medline

To the Editor: 致编辑

In the patient-level meta-analysis of the ARISE, Protocolized Care for Early Septic Shock (ProCESS), and Protocolised Management in Sepsis (ProMISe) trials, the authors conclude that EGDT did not result in better outcomes than usual care. Their findings contradict the findings of Rivers et al.1


The key to the divergent findings between these trials and the trial conducted by Rivers and colleagues lies mainly in the medical management in the usual-care group.2,3 In the trial by Rivers et al., the amount of fluids administered and the mean central venous pressure achieved in the first 6 hours of treatment were significantly lower in the usual-care group (the standard-therapy group) than in the early-therapy group. In contrast, in the recent trials, early, aggressive, and targeted resuscitation, the hallmark of EGDT, was achieved even in the usual-care group. Thus, the differences between the usual-care groups and the early-therapy groups in the recent trials were limited to the monitoring of central venous oxygen saturation and the use of dobutamine and blood transfusions toward predefined central venous oxygen saturation targets.


After the trial by Rivers et al., early, goal-directed, protocol-based resuscitation of patients with septic shock became the norm. If “usual care” has now evolved to involve early, targeted administration of antibiotics, fluids, and vasopressors, it is to the credit of EGDT.


Sahajal Dhooria, M.D., D.M.

Inderpaul S. Sehgal, M.D., D.M.

Ritesh Agarwal, M.D., D.M.

Postgraduate Institute of Medical Education and Research, Chandigarh, India

No potential conflict of interest relevant to this letter was reported.


1. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345:1368-1377 Free Full Text | Web of Science | Medline

2. Dhooria S, Agarwal R. “Early goal-directed therapy” versus “early” and “goal-directed” therapy for severe sepsis and septic shock: time to rationalize. Lung India2015;32:521-523 Web of Science | Medline

3. Levy MM. Early goal-directed therapy: sorting through confusion. Lung India2015;32:435-436 CrossRef | Web of Science | Medline


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