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]<mailto:[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]<mailto:[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]<mailto:[email protected]> http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org
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