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]>
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]>> 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]>>
 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]>
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]>> 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>


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