Recently, I got to talk to Sean Townsend, MD; a critical care doc and a member of the Surviving Sepsis Campaign (SSC) steering committee. The spark for this conversation was the recent SSC response to the ProCESS trial (read below) as well as the elimination of CVP and ScvO2 from the National Quality Forum (NQF) sepsis bundle.
- Harmonization Paper that Dr. Townsend Mentioned (Intensive Care Med. 2013 Oct;39(10):1760-75.)
- Definitely read this editorial on legislating sepsis care
- Here is the SSC response to ProCESS:
Surviving Sepsis Campaign Responds to ProCESS Trial
The Surviving Sepsis Campaign (SSC) has received many inquiries regarding the recent publication of the Protocol-Based Care for Early Septic Shock (ProCESS) trial’s effect on the continuing activities of the Campaign.
- The ProCESS trial reflects the consensus that early diagnosis of septic shock is essential. Notably, all groups in the study received on average more than 2 liters of fluid prior to randomization and more than 75% received antibiotics prior to randomization–both elements of the 3-hour Surviving Sepsis Campaign bundle. (2) The editorial accompanying the ProCESS study highlights these points. (3)
- The 18% mortality rate in the “usual care” arm of ProCESS illustrates a dramatic change in the management and outcomes of patients with septic shock. (1) In comparison, septic shock mortality was 46.5% in the 2001 early goal-directed therapy trial by Rivers. (4) Given that 70% of the hospitals in ProCESS had some form of “sepsis protocol,” we believe this mortality rate demonstrates the success of the SSC in increasing awareness and attention to the challenge of early identification and management of these vulnerable patients.
- Given the remarkably low mortality rate in the control arm of ProCESS, the existence of sepsis protocols in the majority of participating study institutions, and the pending results of 2 large ongoing trials (the Australian Resuscitation In Sepsis Evaluation Randomised Controlled Trial [ARISE] and The Protocolised Management in Sepsis Trial [ProMISe]), the SSC has no plans to revise the bundles or National Quality Forum (NQF)-endorsed measures at this time.
- ProCESS does not address the protocolized management of patients with severe sepsis without septic shock, a group of patients for whom early detection and treatment remain critical. The aggressive protocolized management of these patients who do not yet have shock has likely lowered severe sepsis and septic shock mortality since the inception of the SSC. The recently formed Society of Critical Care Medicine/Society of Hospital Medicine (SCCM/SHM) Early Diagnosis and Treatment of Severe Sepsis on the Hospital Floors Collaboratives will focus in large part on this population. Further, the ProCESS results have no impact on the 3-hour bundle, which is the primary focus for the Collaboratives.
- Regarding the SSC 6-hour bundle:
- A companion paper appears to support a mean arterial pressure (MAP) target of 65 mm Hg, which is one of the indicators in this bundle. (5)
- The ProCESS paper does not address repeating lactate measures in patients with elevated lactate while literature supports doing so. (6,7)
- The majority of the patients in the usual care (56.5%) and protocol-based standard care arms (57.9%) of ProCESS had central lines inserted as part of clinical care. (1) The 6-hour bundle asks only that central venous pressure (CVP) be measured and that a venous blood gas be sent from that line to obtain the central venous oxygen saturation (ScvO2). The ProCESS manuscript does not state how the CVP line was used in the usual care arm nor in the protocol-based standard therapy arm. Similarly, the NQF-endorsed measures of SSC do not set targets for these variables so credit is given for simple collection of the results. (8)
The Surviving Sepsis Campaign looks forward to additional evidence regarding the optimal resuscitation of patients with severe sepsis and septic shock. Given the existing evidence supporting early targeted resuscitation in these patients, SSC continues to recommend all elements of the current bundles.
1. Yealy DM, Kellum JA, Juang DT, et al: A randomized trial of protocol-based care for early septic shock. N Engl J Med 2014; DOI: 10.1056/NEJMoa1401602
2. 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
3. Lilly CM. The ProCESS Trial –a new era of sepsis management. N Engl J Med 2014; DOI: 10.1056/NEJMe1402564
4. 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
5. Asfar P, Meziani F, Hamel JF, et al. High versus low blood-pressure target in patients with septic shock. N Engl J Med 2014; DOI: 10.1056/NEJMoa1312173
6. Jones AE, Shapiro NI, Trzeciak S, et al. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA 2010: 303:739-746
7. Jansen TC, van Bommel J, Schoonderbeek FJ, et al. LACTATE study group: Early lactate-guided therapy in intensive care unit patients: A multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med 2010; 182: 752-761