In this episode, I’ll discuss the latest trial on vitamin C, thiamine, and hydrocortisone for sepsis.
The latest trial of this protocol to be published is again in JAMA in February 2021. 501 septic patients were randomized between the vitamin C, thiamine, hydrocortisone protocol and placebo. This was a multicenter randomized double blind controlled trial. The authors found no difference between groups in ventilator- and vasopressor-free days within 30 days.
These results, when added to existing studies, are disappointing as they appear to show no benefit to this strategy that was supposed to be a cure for sepsis. Besides the results, two additional circumstances regarding this study are also disappointing.
First, the trial was stopped well short of the planned enrollment due to a withdrawal of funding. A withdrawal of funding after a trial has started is highly unusual. The reason given was simply that the research priorities of the sponsor had changed. This leaves open the possibility that the trial was underpowered to detect a difference between groups.
A second and equally unusual issue was the multiple roles that a particular author played in the study. One individual was involved with the initial design of the study, participated in the statistical analysis and interpretation of the data, is listed as an author of the article, and served as chair of the Data Safety and Monitoring Board. This blending of roles is very concerning as a DSMB member should neither be involved in the statistical analysis and interpretation of study data nor should they be an author of the study as this gives them a professional interest in the publication of the study and is therefore a potential conflict of interest. The circumstances were noteworthy enough that the editors of JAMA published an editorial alongside the main article describing both of these issues with the study.
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