This week I had the chance to give a webinar on Medicare and sepsis policy (primarily the SEP-1 measure) for Sepsis Alliance:
I've put the 50-slide deck in the cloud, here.
I ran across a tweet, I believe dated June 5, 2020, looking back on the early pivotal sepsis bundle studies:
https://twitter.com/SepsisAlliance/status/1268975224097083393
This leads to a 2014 article at Pittsburgh Medicine on both Dr. Emanuel Rivers' critical early study published in 2001, and a later large RCT by Dr Derek Angus published in 2014.
The 2014 article by Jenny Blair is here:
https://www.pittmed.health.pitt.edu/story/big-beautiful
(Cloud archive of Blair, here.)
For the original research, see Rivers et al., November 8, 2001, NEJM 345:1368-77.
https://www.nejm.org/doi/full/10.1056/nejmoa010307
In a 260-patient RCT, "goal directed therapy" led to a mortality improvement from 46% (SOC) to 30%.
A key feature was central venous monitoring:
The patients assigned to early goal-directed therapy received a central venous catheter capable of measuring central venous oxygen saturation (Edwards Lifesciences, Irvine, Calif.); it was connected to a computerized spectrophotometer for continuous monitoring. Patients were treated in the emergency department according to a protocol for early goal-directed therapy (Figure 2) for at least six hours and were transferred to the first available inpatient beds. Monitoring of central venous oxygen saturation was then discontinued.
The 2014 paper by Angus et al. was the ProCESS trial of "protocol based care for septic shock." See NEJM, May 1, 2014, 370:1683-93
https://www.nejm.org/doi/full/10.1056/nejmoa1401602
In 31 ER's, patients were assigned randomly to one of 3 groups, with about n=450 in each group: protocol guided therapy, protocol therapy without a central venous catheter, and usual care. "There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support".
ProCESS had an Op Ed by Craig Lilly: NEJM 370:1750-51.
https://www.nejm.org/doi/full/10.1056/NEJMe1402564?query=recirc_curatedRelated_article
While ProCESS showed no incremental benefit to the central catheter, it may be that physicians had largely internalized SEP-1 type decisions and maneuvers which were so much a "standard of care" that assignment to an "evidence based protocol" didn't add much.
Writing: "Another interesting and seemingly paradoxical finding is that patients in whom sepsis was managed without a protocol had an outcome as good as those in patients in whom the sepsis was managed with the use of a protocol. If one assumes that the treatments for septic shock, as well as the timing of the treatments, that would be administered in all emergency departments, regardless of size or available resources, would be equivalent to those used in the no-protocol (usual-care) group of the ProCESS trial (which included strategies for early recognition of sepsis), one could come to the dubious conclusion that protocols and decision prompts do not have a role in the treatment of septic shock. I prefer to think differently. I believe that the prompting, serum lactate screening and assessment of SIRS criteria, and reporting of activities that were parts of the study by Rivers et al. and the ProCESS trial can be applied in clinical practice to ensure early diagnosis and treatment for all patients with septic shock."
There were pro-and-con letters to the editor; see NEJM July 24, 2014, 371:384-7.
https://www.nejm.org/doi/full/10.1056/NEJMc1406745?query=recirc_curatedRelated_article
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Not directly related to the above, see an article by Seymour et al...Angus, "Derivation, Validation, Potential Treatment Implications of Novel Clinical Phenotypes for Sepsis," JAMA May 28, 2019, 321:2003-2017.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537818/
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For my informal bibliography of about 25, recent 2019-2020 papers on the CMS SEP-1 metric:
https://drive.google.com/file/d/1tzTkX9gVkEm5-0LFArKvdbADvEO6hsiY/view?usp=sharing
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