1-Hour Bundle - Flimsy Evidence for New "Standard of Care"

Written by Clay Smith

Spoon Feed
Evidence for the 1-hour bundle release by the Surviving Sepsis Campaign is weak. Yet, this is the new standard we are held to, despite ACEP, AAEM, and thousands of physicians, EM and non-EM alike, voicing concern that this is a very bad idea.

Why does this matter?
In April 2018, a 1-hour sepsis bundle was proposed. This is now a replacement and composite of the former 3 and 6 hour bundles. There was immediate backlash, which led to vigorous open debate and a seeming retraction by SCCM made jointly with ACEP. Despite this debate and continued opposition by ACEP and AAEM, the Surviving Sepsis Campaign has released an “updated” version of the 1-hour bundle that looks exactly the same except the start time is not ED triage but upon “recognition of sepsis.” The problem with the 1-hour bundle is that the evidence for this international guideline is retrospective in nature and may support one element, early antibiotics, but all other elements lack a solid evidentiary basis.

Here is a summary of the 1-hour bundle.

From cited article

From cited article

Not a bundle of joy
Dr. Kalantari and Dr. Salim Rezaie (of REBEL EM) unpack the evidence for the 1h sepsis bundle.

  • Definition of sepsis (see Table below*) - Simply put, the 1-hour bundle doesn’t specify how to define it: Sepsis 2.0, CMS, Sepsis 3.0, or Surviving Sepsis 2016. If Sepsis 3.0, qSOFA lacks sensitivity for ED use. “There is no gold standard definition [of sepsis] established to trigger any resuscitative cascade.”

  • Sepsis bundles/Protocol-driven care - Authors of the 1-hour bundle state, “The compelling nature of the evidence in the literature…has demonstrated an association between compliance with bundles and improved survival in patients with sepsis and septic shock.” What is this compelling evidence? It consists of Seymour, et al, a retrospective study that showed mortality benefit in septic shock but not sepsis. Did we not learn that protocolized sepsis care for septic shock didn’t help in three major RCTS: ARISE, ProMISe and ProCESS?

  • Time zero in the ED - When should the clock start on the 1-hour bundle? The first iteration said upon ED triage. The updated version says upon recognition of sepsis. The authors make it sound simple - treat sepsis like a STEMI or trauma alert. That would be great if sepsis had a gold standard definition or black and white presentation. But it doesn’t. In fact, “up to 53% of patients will not demonstrate evidence of severe sepsis or septic shock at time of triage.”

  • Lactate - “None of the studies demonstrated a consistent, clear delineation in which an intermediate lactate level was associated with a sudden increase in mortality, yet we are provided with the cut-off value of 2 mmol/L.”

  • Fluid - “A prescriptive fluid bolus amount that does not consider individual patient needs and comorbidities is potentially deleterious.” The Seymour study providing the “compelling evidence” for this bundle didn’t find benefit to early fluid administration.

  • Antibiotics - The Seymour study found a mortality benefit to antibiotics within the first 3 hours but did not address antibiotics in the first hour. A 2015 metaanalysis found, “no significant survival benefit of administering antibiotics within three hours of ED triage or within one hour of septic shock recognition in severe sepsis and septic shock.” And the randomized 2018 PHANTASi trial with prehospital antibiotic administration, which is about as early as it gets, also showed no mortality benefit.

The Surviving Sepsis Campaign has not rescinded its 1-hour bundle despite poor quality evidence to support it and a raft of physicians as well as two major EM organizations pointing out the serious problems with it. It is a mandate based on low quality evidence that will lead to practice change and possible harm and certainly unintended consequences. Once this is imposed as the standard, it can take years before we see the fallout and even longer to reverse new, bad habits.

Another Spoonful

From cited article

From cited article

Source
Challenging the One-hour Sepsis Bundle. West J Emerg Med. 2019 Mar;20(2):185-190. doi: 10.5811/westjem.2018.11.39290. Epub 2019 Feb 4.

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Reviewed by Thomas Davis

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