This is just a quick post in response to a tweet – and hype-machine press-release – making the rounds today.
This covers a before-and-after study regarding a single-center practice change in an intensive care unit where their approach to severe sepsis was altered to a protocol including intravenous high-dose vitamin C (1.5g q6), intravenous thiamine (200mg q12), and hydrocortisone (50mg q6). Essentially, this institution hypothesized this combination might have beneficial physiologic effects and, after witnessing initial anecdotal improvement, switched to this aforementioned protocol. This report describes their outcomes in the context of comparing the treatment group to similar patients treated in the seven months prior.
In-hospital mortality for patients treated on the new protocol was 8.5%, whereas previously treated patients were subject to 40.4% mortality. Vasopressor use and acute kidney injury was similarly curtailed in the treatment group. That said, these miraculous findings – as they are exhorted in the EVMS press release – can only be considered as worthy of further study at this point. With a mere 47 patients in both treatment groups, a non-randomized, before-and-after design, and other susceptibilities to bias, these findings must be prospectively confirmed before adoption. When considered in the context of Ioannidis’ “Why Most Published Research Findings Are False”, caution is certainly advised.
I sincerely hope prospective, external validation will yield similar findings – but will likewise not be surprised if they do not.
“Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study”
https://www.ncbi.nlm.nih.gov/pubmed/27940189
Thank you for addressing this. I hope he’s right but this is almost exactly how EGDT started. I heard Paul’s revelation on the CCR vodcast and worried that this was the direction we were headed. Hopefully an RCT is in the offing.
I’m really offended by the hype. Marik should be ashamed of himself for using words like “cure.” Any respectable researcher should have the decency and humility to temper the ridiculous fanfare over such a limited study, particularly when the main agent (steroids) has been studied in sepsis plenty. Is this foolishness or egotism? I suspect the latter. Shameful.
I’m willing to take the high ground and hope it’s neither egotism nor foolishness on Marik’s part – and his words have been cherry-picked/distorted by the marketing department to the desired effect. I am all for instituting and observing reasonable practice change and disseminating the results as a challenge for all to replicate – as long as the proper caution is exercised.
Greg, the main ingredient is vitamin c, not steroids. Marik’s use of the word “cure” was not egotism, it was more like astonishment. He could hardly believe the results himself, but after the results repeated 150 times, what was he supposed to do? Sit on his hands? He did not demand its use, the institution he labored at noted the results and it went from there.