I suspect new insights to this question will be answered by the ProCESS study, which is about to enroll the last patient...
https://crisma.upmc.com/processtrial/info2.asp On Wed, May 1, 2013 at 1:47 PM, Townsend, Sean, M.D. < [email protected]> wrote: > Did you happen to know that all patients in that trial received a central > line and that CVP was optimized using it? I think therefore we can’t call > that trial “non-invasive.”**** > > ** ** > > Also, although that trial enrolled 300 patients, the intervention did not > differ until the level of optimizing ScvO2, i.e. all patients that > benefited from CVP, a fluid bolus, antibiotics etc. and met targets > progressively dropped out of the running to actually compare lactate > clearance to ScvO2. Thus, in the end, 29 patients got a head to head > comparison of lactate clearance to ScvO2 optimization.**** > > ** ** > > This would suggest that enrollment in the trial should have been 3000 > patients in order to test the actual difference in intervention at the > power requirement of 300.**** > > ** ** > > One can make the argument reasonably that the assertion of non-inferiority > is underpowered by a factor of 10.**** > > ** ** > > One must also wonder about extraordinarily high lactates. None were > enrolled in the trial. So, if I have a lactate of 9 and clear it by 10% to > 8.1 should I be comfortable that I have hit my resuscitation targets? > Doesn’t make me so comfortable.**** > > ** ** > > Sean R. Townsend, M.D. > Vice President of Quality & Safety > California Pacific Medical Center > 2330 Clay Street, #301 > San Francisco, CA 94115 > email [email protected] > office (415) 600-5770 > fax (415) 600-1541**** > > ** ** > > *From:* [email protected] [mailto: > [email protected]] *On Behalf Of *Ram Parekh > *Sent:* Tuesday, April 30, 2013 1:50 PM > *To:* Vipul Kella > *Cc:* [email protected] > *Subject:* Re: [Sepsis Groups] Noninvasive EGDT**** > > ** ** > > We have at our hospital and at most of the GNYHA hospitals in the New York > area. > > This protocol is based on the non-inferiority study of lactate clearance > by Jones/Shapiro and was implemented with our current Stop Sepsis > collaborative which has given ED providers the option of utilizing the > 'invasive' or 'non-invasive protocol' as EGDT options. Thus, the protocol > was simultaneously implemented in over 50 hospitals at the same time.**** > > On Mon, Apr 29, 2013 at 9:57 AM, Vipul Kella <[email protected]> > wrote:**** > > Has anyone implemented the noninvasive EGDT protocol at their hospital? > What was your experience? > **** > > ** ** > > -- **** > > Vipul Kella, MD FACEP > Medical Emergency Professionals (MEP)**** > > > _______________________________________________ > Sepsisgroups mailing list > [email protected] > http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org** > ** > > ** ** > > _______________________________________________ > Sepsisgroups mailing list > [email protected] > http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org > > -- Erik Kulstad, M.D., M.S. Research Director Advocate Christ Medical Center Dept. of Emergency Medicine 4440 W. 95th St. Oak Lawn, IL 60453 Clinical Associate Professor University of Illinois, Chicago
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