Wonderful e mail and perspective, Sean. I don't often feel motivated to respond to this US group but on this occasion, love it.
R Dr Ron Daniels Chair: UK Sepsis Trust CEO: Global Sepsis Alliance Director: MedEFest Ltd Sent on the move from my iPhone, excuse brevity! > On 22 Jul 2014, at 17:09, "Townsend, Sean, M.D." <[email protected]> > wrote: > > Agree with all that too. I just don't think ProCESS helped us define much. > Think about the absurdity of studying usual care. Once you publish your > findings what was usual is contaminated by your conclusions. Practice > changes and what you publish changes your practice. You can study it now, in > 5 years, in 10 years and come to different conclusions. It's a great way to > stay perpetually NIH funded. The fabulous never ending study of "the usual." > > Sean R. Townsend, M.D. > Vice President of Quality & Safety > California Pacific Medical Center > 2330 Clay Street, #301<x-apple-data-detectors://0/0> > San Francisco, CA 94115<x-apple-data-detectors://0/0> > email [email protected]<mailto:[email protected]> > office (415) 600-5770<tel:(415)%20600-5770> > fax (415) 600-1541<tel:(415)%20600-1541> > > On Jul 22, 2014, at 10:48 AM, "Kramer, George C." > <[email protected]<mailto:[email protected]>> wrote: > > one religion is be have the good docs that can perform all of the of > detective work on the clues and find the culprit and device the right plan to > apprehend or cure. > > another religion is find the good docs, get them to better define their > interpretation and tools and put it into a clinical guideline with some > specificity. These tools should incorporate "imagination and differential > thinking " And the tool helps out for those docs that are spread thin with > too many patient on the unit, or are too young or in the OR and not a bedside. > > The tools should even help the good docs. > > All the docs will deviate from the guidelines often based on rationale based > on circumstances, co-morbiidies, etc. But reducing variability of care is > better care. part of religion 2. And deviations will define better guidelines > for the special circumstances. > > george > > but i am a naive physiologist. > > > > George C. Kramer, PhD. > Professor > Director, Resuscitation Research Lab > Dept. of Anesthesiology > UTMB, Galveston > > mobile 409-939-3040 > Mary 409747-0077 > > > > > > > > > > On Jul 22, 2014, at 8:10 AM, Joseph J. Bander > <[email protected]<mailto:[email protected]>> wrote: > > Amen > > > Sent from my Verizon Wireless 4G LTE smartphone > > > -------- Original message -------- > From: "Townsend, Sean, M.D." > Date:07/22/2014 9:08 AM (GMT-05:00) > To: "Kramer, George C." > Cc: Sue Beswick ,Richard Teplick ,"" > Subject: Re: [Sepsis Groups] Impact of ProCESS study on your protocols > > No offense to anyone here, but this type of measurement is ubiquitous in > medicine. We measure blood pressure, which tells us what directly again? We > measure heart rate, which tells us tamponade or afib or digoxin overdose -- > no direct correlation -- but plenty of indirect correlation. We measure > train of 4 -- same. So no physiologic measurement tells us much about > disease directly. We measure elevated RVSP and might have PE or pulmonary > hypertension or something else. > > We are stuck with imagination and differential thinking and that's what makes > a good doc versus someone reading the meter. ScvO2 is a clue. 80% or more > if the time it adds to the picture rather than subtracts info. > > It's more like resolution of a photograph. More pixels = more information. > Maybe you like looking at blurry pictures or limiting your pixels. The > ostrich keeps it's head in the ground. I don't know any more....ProCESS > people seem happy to know less and make decisions anyway. > > Sean R. Townsend, M.D. > Vice President of Quality & Safety > California Pacific Medical Center > 2330 Clay Street, #301<x-apple-data-detectors://0/0> > San Francisco, CA 94115<x-apple-data-detectors://0/0> > email > [email protected]<mailto:[email protected]><mailto:[email protected]> > office (415) 600-5770<tel:(415)%20600-5770> > fax (415) 600-1541<tel:(415)%20600-1541> > > On Jul 21, 2014, at 9:33 AM, "Kramer, George C." > <[email protected]<mailto:[email protected]><mailto:[email protected]>> wrote: > > what about urinary output? > > it is the gold standard for burn shock a type of shock with high > permeability, loss of vascular volume, depressed cardiac contractility, SIRS, > > hmm, that sound similar to sepsis. > > g > > > On Jul 18, 2014, at 11:13 AM, Richard Teplick > <[email protected]<mailto:[email protected]><mailto:[email protected]>> > wrote: > > One obvious problem with the initial study (Rivers) is that SvO2 is that > cannot possibly uniquely reflect adequacy of organ perfusion; at best it > reflects extraction. Because of the disparity in organ blood flow and > autoregulatory reserve, low flow to, for example, the kidneys could never be > detected in the presence of high muscle and skin flow (both of which > generally occur in septic shock). Moreover, elite aerobic athletes can reduce > their PvO2 to the teens producing SvO2s < 0.3. Yet they clearly have adequate > muscle and skin flow although gut and renal flow may be reduced and may have > low SvO2 but this cannot be determined from the SvO2 alone. Moreover, giving > fluid to increase cardiac output may not alter blood flow to vital organs. > My point is that we shouldn’t blindly accept study results that are > physiologically unsound. I am most interested in other opinions. > > Dick > > From: Sepsisgroups > [mailto:[email protected]<mailto:[email protected]>] > On Behalf Of Ron Elkin > Sent: Thursday, July 17, 2014 17:13 > To: Sue Beswick > Cc: > [email protected]<mailto:[email protected]><mailto:[email protected]> > Subject: Re: [Sepsis Groups] Impact of ProCESS study on your protocols > > Hi Sue, > > The study has certainly generated a buzz. For objective, serious students of > this disease, however, the study should raise serious concerns about > protocol, data, and conclusions. I'm sure these will be addressed in medical > and other nursing forums in the months to come. > > A few comments or questions as examples: > > 1) "Usual care" has been irrevocably changed since publication of the EGDT > study in 2001, as well as guidelines from SSC supported by many of our > professional societies. Indeed sepsis management protocols existed in many of > the ProCESS hospitals, so the control groups, protocol-based (PB) standard > care and usual care, were treated by physicians well versed in EGDT protocols. > > > 2) The mortality rates in each study group were unexpectedly and remarkably > low, around 20%, and probably not representative of the mortality rates for > similar patients in most US hospitals. As a result of the low mortality rate, > some question whether the study was adequately powered to examine differences > between study groups, and whether the study is generalizable to 5000 US > hospitals. > > Moreover, why abandon measures that contributed to such impressive mortality > reductions? Are we immune to regressive behavior if practice guidelines are > relaxed or removed? > > > 3) The protocol instruction for the first 6 hours was to avoid central line > placement, CVP measurement, and ScvO2 in both control groups, PB standard > care and usual care, unless peripheral access was inadequate. Yet, over 55% > of patients in these groups received them for unstated reasons. One might > reasonably speculate they were placed for hypotension and administration of > vasopressors. Not stated, however, is how often these lines were utilized for > CVP measurements that confirmed or guided resuscitation. > > In the transcript of a recent NQF conference call, available to the public, > an author of the study stated CVP measurements were documented in about 1/3 > of the control patients but were not used to guide therapy as evidenced by > the lack of followup measurements. However, almost any experienced clinician > will act similarly on some single measurements - a patient with a CVP of 3 on > vasopressors will almost always receive volume. > > Also not reported are the number of control patients with lines who had ScvO2 > measurements, except for the few who received continuous oximetry lines. It > also remains possible that blood sample measurements of ScvO2 were utilized > in control patients, but this is not addressed in the manuscript. > > We don't know how often CVP and ScvO2 measurements were made in control > patients with central lines before randomization. We don't know how often > clinicians acted on CVPs estimated by bedside neck exam, vertical column > height of blood in the lines that were inserted, or IVC dimensions and change > with respiration. > > We don't know how many lines, CVPs, and ScvO2s were added in the control > groups after the protocol instructions expired at 6 hours. It is still > possible and beneficial to rescue an inadequate resuscitation beyond 6 hours. > > In short, we don't know enough about management of the control groups. > > > 4) Protocol non-adherence was reported in 11.9% but information in the > appendix suggests higher. MAP goals were achieved in only 83%. Overall bundle > compliance is not reported. > > In short, we don't know enough about the quality of management in the EGDT > group. > > > 5) Not reported are statistical comparisons between all study patients with > lines versus without, control patients with lines versus without, and each of > the 2 control group. > > > So in summary, care in any of the study groups is not adequately described, > and care in the control groups appears to be significantly contaminated by > EGDT. I for one do not favor protocol changes on the basis of this study at > this time, and I know for a fact that I have a lot of company. > > Thanks > > Ron Elkin MD > California Pacific Medical Center > San Francisco, CA > > On Thu, Jul 17, 2014 at 6:23 AM, Sue Beswick > <[email protected]<mailto:[email protected]><mailto:[email protected]>> wrote: > Is anyone adapting their protocols with the findings that came out this year > with the ProCESS study? > We are looking at making some changes. > > Sue > > Sue Beswick APRN, MS, CCNS, CCRN > CNS Critical Care > Greenville Health System > 701 Grove Road l Greenville, SC 29605 > Office: 864-455-4884<tel:864-455-4884> > > > _______________________________________________ > Sepsisgroups mailing list > [email protected]<mailto:[email protected]><mailto:[email protected]> > http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org > > _______________________________________________ > Sepsisgroups mailing list > [email protected]<mailto:[email protected]><mailto:[email protected]> > http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org > > _______________________________________________ > Sepsisgroups mailing list > [email protected]<mailto:[email protected]><mailto:[email protected]> > http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org > _______________________________________________ > Sepsisgroups mailing list > [email protected]<mailto:[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 _______________________________________________ Sepsisgroups mailing list [email protected] http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org
