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March - 2014

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A Randomized Trial of Protocol-Based Care for Early Septic Shock

The ProCESS Investigators NEJM, 2014, online first 18th Mar 2014

Comment

The ProCESS trial is the first of the 3 big EGDT sepsis trials (ProCESS- US, ARISE-Aust/NZ, ProMISe - UK) to be published.  

These 3 trials form the multi-centre response to the Rivers trial, and are all must read, must know evidence, as they will be debated at...

March



Previous Comments

I would have thought this was pretty obvious. It stands to reason that protocols are more likely to be of assistance in circumstances where it is difficult to achieve important interventions in a timely fashion. This includes a) when interventions need to be implemented very quickly, b) where the volume of patients is low, c) where the resources required are scarce, and d) where the level of training is less. That is, exactly the sort of places that were NOT in this trial. It seems very unlikely that any of these 3 trials are going to show a benefit, but to me, this doesn't disprove the likely value of an aggressive, protocolised approach in the centres that need it.
Dale-13 Apr, 2014 09:36:18 AM

Misleading statistics. 60 day in-hospital mortality does not account for those that die after discharge before day 60 (these are considered "Alive"). Real mortality is higher.
Simon-14 Apr, 2014 11:44:00 AM

I have to agree with Dale. For me, from the public health perspective, the Rivers trial was a triumph. It showed that in regions of low socioeconomic status and high levels of comorbidities/poor access to community care/late presentation we can decreased sepsis mortality by A LOT. Worldwide, the highest sepsis mortality occurs in areas and to people with low access to academic Ivory Towers and ICU beds. Context matters. And isn't goal directed therapy 'what we do'? We aim for normal physiological states, we aim for less pain, we aim to prolong life… Nevermind the Hawthorne Effect and that the entire intensive care community, at multitudes of conferences and podcasts and fellowship exams, for the last four years has been inundated with the surviving sepsis campaign which probably significantly contaminates any control group. At risk of challenging the very core of the question - why did we go on to do three massive international studies to ask this question? I think we really did it so that we didn't have to use dobutamine and cvp's to guide our resuscitation but the side-effect might be that people stop paying attention again because we have a study that shows it doesn't seem to matter? I don't believe this is true and I think to propagate it does a disservice to those areas operating on the edge of need where no research occurs… where resources are strained and in fact, paying more attention might actually bring sepsis mortality down like it did in the River's study?
smokey-25 Jun, 2014 06:58:48 PM

I have to agree with Dale. For me, from the public health perspective, the Rivers trial was a triumph. It showed that in regions of low socioeconomic status and high levels of comorbidities/poor access to community care/late presentation we can decreased sepsis mortality by A LOT. Worldwide, the highest sepsis mortality occurs in areas and to people with low access to academic Ivory Towers and ICU beds. Context matters. And isn't goal directed therapy 'what we do'? We aim for normal physiological states, we aim for less pain, we aim to prolong life… Nevermind the Hawthorne Effect and that the entire intensive care community, at multitudes of conferences and podcasts and fellowship exams, for the last four years has been inundated with the surviving sepsis campaign which probably significantly contaminates any control group. At risk of challenging the very core of the question - why did we go on to do three massive international studies to ask this question? I think we really did it so that we didn't have to use dobutamine and cvp's to guide our resuscitation but the side-effect might be that people stop paying attention again because we have a study that shows it doesn't seem to matter? I don't believe this is true and I think to propagate it does a disservice to those areas operating on the edge of need where no research occurs… where resources are strained and in fact, paying more attention might actually bring sepsis mortality down like it did in the River's study?
smokey-25 Jun, 2014 07:34:11 PM