Trial of Early, Goal-Directed Resuscitation for Septic Shock

Mouncey, Paul; Osborn, Tiffany M.; Power, G Sarah; Harrison, David A; Sadique, Zia; Grieve, Richard; Jahan, Rahi; Harvey, Sheila; Bell, Derek; Bion, Julian; Coats, Timothy J; Singer, Mervyn; Young, John; Rowan, Kathy; Act, Abstr

doi:10.1056/nejmoa1500896

Cited by 1,310 publications

(955 citation statements)

References 23 publications

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“…Three RCTs110, 111, 112 conforming to the PICO process were identified based on a search of the PubMed database and were used in the final analysis for this CQ. Regarding the 90‐ and 28‐day mortality rates, EGDT was not effective in improving mortality rate in comparison to the standard treatment [90‐day mortality rate: risk ratio: 0.98 (95% confidence interval [CI]: 0.88–1.10); 28‐day mortality rate: risk ratio: 0.98 (95% CI: 0.84–1.13)].…”

Section: Cq7: Initial Resuscitation/inotropesmentioning

confidence: 99%

“…As such, it was concluded that an expert consensus should be offered, as the evidence for this CQ is inadequate to support a recommendation. In addition, in three large‐scale RCTs evaluating the effectiveness of EGDT (ProCESS,110 ARISE,111 and ProMISe112), when the differences in intergroup (EGDT group versus standard treatment group) total volume of fluid transfused prior to study protocol initiation were calculated, the following differentials were revealed: ProCESS (2.3 ± 1.5 L versus 2.1 ± 1.4 L), ARISE (2.5 ± 1.2 L versus 2.6 ± 1.3 L), and ProMISe (1.9 ± 1.1 L versus 2.0 ± 1.1 L). All the subjects had already received over 30 mL/kg of crystalloid solution during the initial resuscitation prior to group assignment.…”

Section: Cq7: Initial Resuscitation/inotropesmentioning

confidence: 99%

“…was strongly recommended in both the Surviving Sepsis Campaign Guidelines (SSCG) 201229 and the Japanese Clinical Practice Guidelines for the Management of Sepsis and Septic Shock (1st edition) 2. However, the three large‐scale randomized controlled trials (RCTs; Protocolized Care for Early Septic Shock [ProCESS],110 Australasian Resuscitation in Sepsis Evaluation [ARISE],111 and Protocolised Management in Sepsis [ProMISe]112) subsequently reported in 2014 and 2015 failed to demonstrate the usefulness of EGDT. As such, the guideline committee for this clinical question (CQ) conducted a systematic review based on the question, “CQ7‐1: Is EGDT recommended for initial resuscitation in patients with sepsis or septic shock?” The EGDT discussed herein refers to the resuscitation method proposed by Rivers et al 109.…”

Section: Introductionmentioning

confidence: 99%

“…A detailed assessment of these RCTs110, 111, 112 revealed that large‐volumes of fluid (crystalloid solution 30 mL/kg or more) had already been given before protocol initiation. Therefore, the guideline committee for this CQ concluded that the methods of initial fluid resuscitation should be assessed separately from the EGDT intervention, and the next CQ was presented, “CQ7‐2: What volume of fluid should be given in the initial resuscitation of patients with septic shock?”…”

Section: Introductionmentioning

confidence: 99%

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The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016)

Nishida

Ogura

Egi

et al. 2018

Acute Medicine & Surgery

157

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Background and PurposeThe Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016), a Japanese‐specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 in Japanese. An English‐language version of these guidelines was created based on the contents of the original Japanese‐language version.MethodsMembers of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ), and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two‐thirds (>66.6%) majority vote of each of the 19 committee members.ResultsA total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J‐SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation and its supporting evidence were also added to each recommendation statement. We conducted meta‐analyses for 29 CQs. Thirty seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for 5 CQs.ConclusionsBased on the evidence gathered, we were able to formulate Japanese‐specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non‐specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals.

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Section: Cq7: Initial Resuscitation/inotropesmentioning

confidence: 99%

Section: Cq7: Initial Resuscitation/inotropesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016)

Nishida

Ogura

Egi

et al. 2018

Acute Medicine & Surgery

157

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show abstract

“…In this issue of Intensive Care Medicine, Peake and colleagues [11] report a systematic review with metaanalysis of five RCTs [1,[8][9][10][11][12] showing no difference in mortality between ED-initiated EGDT versus usual care groups. However, the ED-initiated EGDT group had significantly more use of vasopressors and duration of stay in the ICU.…”

mentioning

confidence: 99%

Early goal-directed therapy: from discovery through enthusiasm to equipoise?

2015

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The original Rivers trial [1] of early goal-directed therapy (EGDT) discovered that a process of EGDT that guided fluids, vasopressors, inotropic agents and transfusions in the first 6 h of sepsis dramatically reduced mortality (relative risk reduction, RRR of 42 %) compared to usual care in an emergency department (ED) setting. That discovery ushered in an exciting era of early identification, resuscitation and monitoring of patients with sepsis. Since 2003, EGDT has been recommended in international sepsis guidelines [2][3][4], and implementation in routine care has been associated with benefits [5]. Likewise, many observers suggested that prompt recognition and treatment of sepsis may partly explain declining mortality from sepsis [6,7].Some have suggested that EGDT as described in Rivers' trial may not apply to the intensive care setting, because it was a single-centre trial conducted in the emergency department, the control mortality rate was higher than expected, and baseline central venous oxygen saturation (ScvO 2 ) was remarkably low (about 50 %)-an observation thought to be rare in septic ICU patients. Accordingly, many argued that there was clinical equipoise about the role of EGDT in ICU patients with sepsis, and several subsequent multicentre RCTs [8-10] did not find survival benefits from EGDT (mortality was actually slightly higher in EGDT than the usual care group in ProMISe).In this issue of Intensive Care Medicine, Peake and colleagues [11] report a systematic review with metaanalysis of five RCTs [1,[8][9][10][11][12] showing no difference in mortality between ED-initiated EGDT versus usual care groups. However, the ED-initiated EGDT group had significantly more use of vasopressors and duration of stay in the ICU. Peake and colleagues [11] also reviewed six RCTs of non-ED-initiated EGDT, again finding no difference in mortality between EGDT versus usual care. The systematic review adheres to current standards for the conduct and reporting of a systematic review [13,14], including a pre-experimentally published protocol, a comprehensive search strategy, adequate conventional cumulative meta-analyses, relevant sensitivity and subgroup analyses, and adequate assessment of risk of bias. Conventional cumulative meta-analyses are at risk of producing random errors because of sparse data and repetitive testing of accumulating data [15][16][17]. The risk of random errors can be assessed by trial sequential analysis (TSA), where trial sequential monitoring boundaries are applied to the conventional meta-analysis. The underlying assumption of TSA is that significance testing and calculation of the 95 % confidence interval are performed each time a new trial result is published or available. TSA depends on the accrued information

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Septic Shock

Seymour

Rosengart

2015

JAMA

117

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IMPORTANCE-Septic shock is a clinical emergency that occurs in more than 230 000 US patients each year.OBSERVATIONS AND ADVANCES-In the setting of suspected or documented infection, septic shock is typically defined in a clinical setting by low systolic (≤90 mm Hg) or mean arterial blood pressure (≤65 mm Hg) accompanied by signs of hypoperfusion (eg, oliguria, hyperlactemia, poor peripheral perfusion, or altered mental status). Focused ultrasonography is recommended for the prompt recognition of complicating physiology (eg, hypovolemia or cardiogenic shock), while invasive hemodynamic monitoring is recommended only for select patients. In septic shock, 3 randomized clinical trials demonstrate that protocolized care offers little advantage compared with management without a protocol. Hydroxyethyl starch is no longer recommended, and debate continues about the role of various crystalloid solutions and albumin.

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Trial of Early, Goal-Directed Resuscitation for Septic Shock

Cited by 1,310 publications

References 23 publications

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016)

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016)

Early goal-directed therapy: from discovery through enthusiasm to equipoise?

Septic Shock

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