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ProCESS ARISE

The document discusses the preliminary results of the ARISE trial which failed to show benefit from early goal-directed therapy versus controls, similar to findings from the ProCESS trial. The Surviving Sepsis Campaign will review evidence and guidelines and assess whether updates are needed, but current bundles will not change until a thorough review is completed.

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Erick Romero
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14 views2 pages

ProCESS ARISE

The document discusses the preliminary results of the ARISE trial which failed to show benefit from early goal-directed therapy versus controls, similar to findings from the ProCESS trial. The Surviving Sepsis Campaign will review evidence and guidelines and assess whether updates are needed, but current bundles will not change until a thorough review is completed.

Uploaded by

Erick Romero
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Surviving Sepsis Campaign Statement Regarding Hemodynamic and Oximetric Monitoring in

Response to ProCESS and ARISE Trials


October 1, 2014

The preliminary results of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial were
released this week at the European Society of Intensive Care Medicine (ESICM) annual meeting
in Barcelona. The trial failed to show benefit from early goal-directed therapy1 versus controls.
The results of this trial come less than a year after the Protocolized Care for Early Septic Shock
(ProCESS) trial2 released similar findings. The Surviving Sepsis Campaign (SSC) has long believed
that both the SSC guidelines3 and the SSC performance improvement indicators will evolve as
new evidence that improves our understanding of how best to care for patients with severe
sepsis and septic shock is made available. Based on the release of the ProCESS and ARISE trials,
the SSC Executive Committee states:

 Required monitoring of central venous pressure (CVP) and central venous oxygen saturation
(ScvO2) via a central venous catheter as part of an early resuscitation strategy does not
confer survival benefit in all patients with septic shock who have received timely antibiotics
and fluid resuscitation compared with controls.
 Requiring measurement of CVP and ScvO2 in all patients who have lactate results >4 mmol/L
and/or persistent hypotension after initial fluid challenge and who have received timely
antibiotics is not supported by the available scientific evidence.
 The results of the ProCESS and ARISE trials have not demonstrated any adverse outcomes in
the groups that utilized CVP and ScvO2 as end points for resuscitation. Therefore, no harm
exists in keeping the current SSC bundles intact until a thorough appraisal of all available
data has been performed.
 Newly published data from the SSC
(http://journals.lww.com/ccmjournal/Abstract/publishahead/Surviving_Sepsis_Campaign__
_Association_Between.97431.aspx; http://link.springer.com/article/10.1007/s00134-014-
3496-0)
confirm that adherence to quality improvement measures in severe sepsis and septic shock
is associated with mortality decline.
 In light of the evidence from the ProCESS and ARISE trials, the SSC guidelines committee will
immediately review the evidence and assess whether the guidelines need to be updated
now. If that is the case, the committee will develop a focused update.
 The SSC bundles will also be reviewed and revised as needed based on the
recommendations.

Effect on SSC Bundles: Until the work group completes its evaluation of the recommendations
and corresponding bundle elements, the current SSC bundles will not change. No suggestion of
harm was indicated with the protocol utilizing the bundles in either trial, and recent published
evidence shows significant mortality reduction using the existing SSC bundles. When revised
bundles become available, they will be posted on the SSC website and the SSC data collection
tool will be modified appropriately. Of note, the 3-hour SSC bundle will not be affected by this
process.

Page 1 of 2
References:

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.

2. Yealy DM, Kellum JA, Juang DT, et al. A randomized trial of protocol-based care for early
septic shock. N Engl J Med. 2014;370:1683-1693.

3. Dellinger RP, Levy MM, Rhodes A, et al. Surviving Sepsis Campaign: International
guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med.
2013;41:580–637.

Page 2 of 2

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