I feel the impressive message from this study is how the efforts of the
Surviving Sepsis Campaign and the Bundle Development have changed how we care
for Septic patients. The data showed that during the pre-randomization phase
the average fluid given by every group was in excess of 2 liters. 75% plus had
received antibiotics and 15% plus had received vasopressors.
The remarkable thing to me is how we have evolved, in at least these
participating institutions, to being comfortable in giving liberal fluids to
septic patient (even though there is a statistical difference between groups,
they all received in excess of 30 ml/kg PBW with an average of 4.3 to 5.5
liters), being aggressive with broad spectrum antibiotics and vasopressors when
needed. The difference in fluid administration did not result in excessive
ventilator use and was adequate to prevent further renal deterioration. We
could argue what the ideal amount of fluid resuscitation is best but in the end
the care delivered in all the groups seemed remarkably the same from a clinical
point of view although there are some statistical differences in fluids and
vasopressor use, the outcomes are the same at least in the participating
institutions. One could argue regarding the statistical differences but bottom
line is that practice has evolved since the beginning of the Surviving Sepsis
Campaign and the introduction of standardized has improved care and lowered
mortality without introducing more complications.
Are setting goals and using protocols needed. That is another question. I
personally feel the way we arrived at better outcomes is directly related to
this process and if abandoned entropy will ensue and outcomes will deteriorate.
We have seen this within the institutions I work at to some degree and the
maintenance of the gains will most likely depend upon our continuing
emphasizing standardized care processes. This is much more difficult to do
allowing care to be random and chaotic. Could invasive measures be abandoned is
the other point of this paper and this has been brought into question. Since
the other ancillary modes of therapy were the same in the groups the question
of steroids and low Vt. Is not addressed.
The other curious finding is although lactate > 4 is a entry criteria, no
lactate data is presented in the paper.
Protocol-based EDGT Protocol-based
Standard Usual Care p-value
Pre-randomization Fluids 2254 + 1472 2226 +
1363 20830 + 1405 0.15
Pre-randomization Antibiotics 75.6% 76.9%
76.1% 0.28
Pre-randomization Vasopressors 19.1% 16.8%
15.1% 0.91
Rand. Time to 6 hours - Fluids 2805 +1957 3285 +
1743 2279 + 1881 <0.0001
Pre + Rand. Time to 6 hours - Fluids 5059 5511
4362
ED Arrival to 6 hours - Antibiotics 97.5% 97.1%
96.9% 0.90
ED Arrival to 6 hours - Vasopressors 54.9% 52.2%
44.1% <0.0001
Random. To 6 hours - Vasopressors 8.2% 7.2%
7.2%
ED Arrival to 6 hours - Mech. Ventilation 26.4% 24.7%
21.7% 0.25
Rand. To 72 hours Total Fluid 7220 + 4621 8175 +
4998 6633 + 4560 <0.0001
Rand. To 72 hours - % given Vasopressors 27.3% 24.0%
22.4% 0.05
Rand. To 72 hours - % Mech. Ventilated 36.20% 34.10%
29.60% 0.10
Terry P. Clemmer, MD
Director: Critical Care Medicine
LDS Hospital
Professor of Medicine
University of Utah School of Medicine
Salt Lake City, Utan 84143
Work Phone: 801-408-3661
Work Fax: 801-408-1668
-----Original Message-----
From: [email protected]
[mailto:[email protected]] On Behalf Of Townsend,
Sean, M.D.
Sent: Saturday, March 22, 2014 7:36 PM
To: Kramer, George C.
Cc: [email protected]
Subject: Re: [Sepsis Groups] Hypoglycemia
Hi George,
I weighed in a bit last week. SSC is working on our more balanced and formal
remarks. I don't think most of us think protocols are dead. In fact, usual
care at most places included protocols whether clear from the manuscript of not
-- I was a resident at Beth Israel Deaconess and I can tell you the MUST
(multiple urgent sepsis therapies) protocol started changing care there as far
back as 2002. So, I don't well understand the assertion in the methods that
the sites didn't have protocols. The Brigham did as well, and so on.
Here are a repeat of my earlier remarks. More to come from us...
The ProCESS results are important because the trial is multi-institutional and
somewhat controlled, several issues need to be critically examined in the
coming days. These results will be better examined by those less invested in
the Campaign than myself and my colleagues. However, some issues to consider
include:
1. There is a question of face validity for mortality rates such as
reported here. Two accompanying papers in the same issue of the NEJM report
severe sepsis mortality rates in the 30% range.
2. Each of these institutions were tertiary care institutions influenced
substantially over the last decade by the work of the Surviving Sepsis
Campaign. Stated differently, ‘usual care’ has been systematically changed by
the SSC over a decade already in terms of early resuscitation through protocols.
3. In all groups, the total % of enrolled patients that had central lines
in 6 hours was approximately 60%. If most institutions on this listserv could
have 60% central line placement, many of us would be very happy and likely have
lower mortality rates.
4. There were 1300 patients excluded from this trial for logistical
reasons. Thus, half the patients were excluded. This extraordinarily high
rate requires further understanding.
5. 75% of enrolling sites had “sepsis protocols” and usual care occurred
in same ED setting as the two protocol-directed arms.
I think we have more to learn about protocolized resuscitation for sepsis.
In many ways all 3 arms were quantitative resuscitation strategies.
The results of ARISE and PROMIS should provide us with further understanding
over time.
Sean
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 Mar 22, 2014, at 7:14 AM, "Kramer, George C."
<[email protected]<mailto:[email protected]>> wrote:
I look forward to comments on the NEJM that shows no benefit to EGDT or even
use of Sepsis protocols in the ED. Are any of the investigators on the
Sepsisgroups.org<http://Sepsisgroups.org> email list? I am sure some of the
leaders of the SSC have some opinions.
ARE PROTOCOLS DEAD?
http://www.nejm.org/doi/full/10.1056/NEJMoa1401602
g
From: Mary Draper
<[email protected]<mailto:[email protected]>>
Date: Thursday, March 20, 2014 4:32 PM
To: "[email protected]<mailto:[email protected]>"
<[email protected]<mailto:[email protected]>>
Cc:
"[email protected]<mailto:[email protected]>"
<[email protected]<mailto:[email protected]>>
Subject: Re: [Sepsis Groups] Hypoglycemia
Interesting, we have not found hypoglycemia in our severe sepsis patient
population.
Mary Draper RN BSN CCRN
Quality Manager-Best Practice Support
Quality Management Supervisor
Office (925) 674-2045<tel:(925)%20674-2045> Cell (925)
451-8792<tel:(925)%20451-8792> Fax (925) 674-2373<tel:(925)%20674-2373>
[email protected]<mailto:[email protected]>
On Mar 20, 2014, at 12:10 PM,
"[email protected]<mailto:[email protected]>"
<[email protected]<mailto:[email protected]>> wrote:
In a recent review of some of our sepsis records, we found a group of patients
who had profoundly low blood sugars (11-40). I don’t hear much about
hypoglycemia in Sepsis as much as hyperglycemia. We are curious how other
hospitals are looking at this and what the plan of care is when this occurs. Is
it part of your sepsis bundles to check blood sugars? Only in diabetics? How do
you treat and follow up?? Thanks in advance,
Susan McKinney, RN
Susan McKinney
Clinical Quality Coordinator-
-Sepsis-VTE
Clinical Effectiveness Team
[email protected]<mailto:[email protected]>
605-484-7381 Cell
605-755-4428-please note new number
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