IFAD Antwerpen 2013

Azriel Perel

Professor and Chairman Department of Anesthesiology and Intensive Care

Sheba Medical Center, Tel Aviv University

Israel

Resuscitation from Severe Sepsis: do we need care bundles?

Disclosure

The speaker is a member of the

Medical Advisory Board of

Pulsion Medical Systems,

Munich, Germany

Consulted until recently to BMEYE, FlowSense, iMDsoft

“Because of the complexity of

hemodynamics in sepsis, the goals of

therapy are much more difficult to

define with certainty than in other forms

of shock.”

Practice parameters for hemodynamic support of sepsis in adult patients. 2004 update.

Hollenberg S et al. Crit Care Med 2004; 32:1928-48

Early goal-directed therapy improves outcome in patients with

severe sepsis and septic shock.

The 6H bundle

The 6H bundle

Rivers, NEJM 2001

“In most patients with septic shock, CO will be optimized at filling pressures (PAOP) between 12-15 mmHg [26].

Increases above this range…increase the risk for developing pulmonary edema.”

26. (III) Packman MJ, Rackow EC: Optimum left heart filling pressure during fluid resuscitation of patients with hypovolemic and septic shock. Crit Care Med 1983; 11:165-9

Level D recommendation

Practice parameters for hemodynamic support of sepsis in adult patients. 2004 update.

Hollenberg S et al. Crit Care Med 2004; 32:1928-48

CCM 2007 35:64-8

Fluid overload!Fluid overload!

Possible hypoperfusion!

Targeting dynamic measures of fluid responsiveness during resuscitation, including flow (CO) and possibly volumetric indices and microcirculatory changes, may have advantages

Rivers, NEJM 2001

The ScvO2 serves as a surrogate of CO

Rivers et al NEJM 2001

The normal ScvO2 is

~70%

Crit Care Med 2006, 34:1025-1032

Initial ScvO2 72 ± 11%

Initial ScvO2 73 ± 13%

Initial ScvO2 74 ± 10%

Initial ScvO2 73 ± 11%

The mean ScvO2 of Rivers’ patients was 50%!!!

A normal/high SvO2 may be due to reduced O2 extraction and does not necessarily indicate

adequate tissue oxygenation

Severe Global Tissue Hypoxia and Low O2 Extraction

Lactate > 4 mmol per liter and ScvO2 >70%

CCM 2007

The extremely low ScvO2 values seen in Rivers’ patients on admission to the ED indicate that these patients had very low cardiac outputs.

The most probable cause for their low CO was a combination of pre-existing co-morbidities and hypovolemia, which may have developed due to a late arrival to the hospital (black, low socioeconomic status, no insurance).

The very significant hypovolemic element of their shock was successfully corrected by aggressive fluid loading which was guided by a simple protocol that may be unsuitable for many ICU septic patients.

Very recent literature from the US emphasizes the effects of race and socio-economic conditions on sepsis outcome.

The Rivers study was done in the Department of Emergency Medicine which serves “metro Detroit’s largely poor, largely minority population, having poor health status and high chronic disease incidence” Ann Emerg Med Dec. 2008

“Outcome of Americans without insurance who are admitted to the ICU is worse, possibly because they are sicker when they seek care.” Danis M, et al. Crit Care Med 2006; 34:2043

Do the Rivers’ patients represent all septic patients?

“Shocked” wouldn't be accurate, since we were accustomed to our uninsured patients' receiving inadequate medical care. “Saddened” wasn't right, either, only pecking at the edge of our response. And “disheartened” just smacked of victimhood. After hearing this story, we were neither shocked nor saddened nor disheartened. We were simply appalled…..

We find it terribly and tragically inhumane that Mr. Davis and tens of thousands of other citizens of this wealthy country will die this year for lack of insurance.

Dr. Rivers's explanation of the higher death

rate for those on conventional care

compared with data from other countries, is

that his patients were sicker.

Rawlins MR: De Testimonio. Harveian oration 2008, Royal College of Physicians

There are only 10 references supporting the 6H bundle; they have not been

updated over the years

Total number of references in the SSCG grew form 135 (2004), to 341 (2008),

and to 636 (2012)

A large number of observational studies

have shown significant mortality reduction

compared to the institutions’ historical

controls.

Crit Care Med 2010; 38:668–678

As administered and studied to date, only

antibiotics meet the stated criteria of proof for

bundle inclusion.

The reported improved survival following the adoption of these (SSC) Guidelines….cannot be viewed as justification of the initial hemodynamic resuscitation protocol.

Physiologically and clinically this protocol may be wrong for many septic patients.

Attainment of a CVP of >8 mmHg and

ScvO2 of >70% did not influence

survival in patients with septic shock*.

*Voluntarily submitted data on 15,022 patients

Rivers EP et al,

Crit Care Med 2010; 38:668–678

Current sepsis bundles may force

physicians to provide unproven

or even harmful care.

Crit Care Med 2011; 39:259-65

778 septic shock pts from the VASST study

The toxic effects of EBM!

“Surely, we recognize the need to give up some measure of autonomy…yield some decision-making power…

The data certainly suggest that when we surrender this autonomy and standardize care, patients do better.”

M. Levy, SCCM 2009

38th SCCM Conference Perspectives

The 3 phases of the SSC

1. Introduction at several major international critical care medicine conferences.

2. Creating evidence-based guidelines for the management of severe sepsis and septic shock.

3. To operationalize the SSC guidelines into a set of practical yet valid performance measure.

The sepsis bundle includes only

recommendations that can be converted into

data elements that can be precisely defined,

with clearly identified failure modes, and that

could be measured by retrospective chart

audit.

The bundle is well-established, proven in scientific tests and based on randomized controlled trials, what we call Level 1 evidence.

C.H. PhD, IHI Vice President and patient safety expert

A bundle must be followed for every patient, every single time. There should be no controversy involved, no debate or discussion of bundle elements.

Addition of other strategies not found in the bundles is not recommended.

The guidelines attempt to include nearly every aspect of critical care potentially related to sepsis, perhaps losing focus in the process.

The evidence behind some of the ‘bundles’ is not strong, e.g., CVP.

These bundles are being turned into quality measures on which providers will be benchmarked, even though clinicians may validly disagree with some of the recommendations.

While only 47% of surveyed intensivists

believed that CVP should guide

resuscitation, 86% used it because of

the Surviving Sepsis Campaign

Guidelines.

Bundled performance

measures are ready made for

use in pay-for-performance

initiatives, which can base

reimbursement on

compliance with all the

components. Are you compliant?

Complete compliance with all applicable elements of the sepsis resuscitation bundle was 21.6% in the USA and 18.4% in Europe.

Even in these highly selected and committed institutions compliance with both the resuscitation and the management bundles was only about 20%.

This suggests that compliance is either quite difficult, or that clinicians disagree with some aspects of the guidelines and specifically do not reach compliance.

http://survivingsepsis.org/Guidelines/Pages/default.aspx

In response to comments and questions, the SSC leadership has provided additional background regarding the guideline recommendation regarding measurement of CVP, ScvO2, and lactate.

The performance indicators for bundle compliance now call for measuring CVP and SCVO2, and re-measuring lactate if the initial lactate was elevated.

The rationale for the indicators’ being measurement and not target achievement is that the decision to give more fluid or add inotropes to the resuscitation should be based on the entire clinical picture.

Institutions that can bring more advanced technologies to the bedside may do so and use those measurements as part of the total clinical picture for decision making.

The performance indicators for bundle compliance now call for measuring CVP and SCVO2, and re-measuring lactate if the initial lactate was elevated.

The rationale for the indicators’ being measurement and not target achievement is that the decision to give more fluid or add inotropes to the resuscitation should be based on the entire clinical picture.

Institutions that can bring more advanced technologies to the bedside may do so and use those measurements as part of the total clinical picture for decision making.

Thank you for your attention!

Conclusions:

Rivers et al have started one of the most important process in modern critical care and the SSC is saving lives as we speak.

And yet, the physiological variables that the SSC recommends to direct the initial hemodynamic resuscitation are not suitable for all septic patients and may be harmful.

Attempts to protocolize care in critically ill patients have to leave room for clinical judgment that takes into account the whole clinical picture.

Sponsoring Organizations

American Association of Critical Care Nurses American College of Chest Physicians American College of Emergency Physicians American Thoracic Society Australian and New Zealand Intensive Care Society European Society of Clinical Microbiology and Infectious

Diseases European Society of Intensive Care Medicine European Respiratory Society International Sepsis Forum Society of Critical Care Medicine Surgical Infection Society

In part, physician noncompliance with evidence-based guidelines can be explained by weaknesses in the evidence base itself.

In recent years, the developers of practice guidelines have started grouping evidence-based interventions into “bundles,” on the theory that inducing physicians to follow multiple recommendations written into a single protocol has a measurable effect on patients’ outcomes.

Seeing in these bundles a potentially powerful vehicle for promoting their products, pharmaceutical and medical-device companies have begun to invest in influencing the adoption of guidelines that serve their own financial goals.

“For every patient, every single time”

“No controversy involved, no debate or discussion”

“Clearly, SvO2 is the gold standard for

defining global adequacy of

cardiovascular performance.”

Crit Care Med 2005; 33:1119-22

It is useful to measure SvO2 because if cardiac output becomes inadequate, SvO2 will decrease.

A low SvO2 should prompt rapid intervention to increase oxygen delivery to the tissues.

https://admin.emea.acrobat.com/_a45839050/p37057603/

“Medicine has become complex. Details have become overwhelming for clinicians to process at the bedside…

Surely, we recognize the need to give up some measure of autonomy…yield some decision-making power…

The data certainly suggest that when we surrender this autonomy and standardize care, patients do better.”

M. Levy, SCCM 200938th SCCM Conference Perspectives

Study Year Country Compliance 6H bundle

Compliance 24H bundle

Overall compliance

Gao F et al 2005 UK 52% 30%

Ferrer R et al 2008 Spain <10%

Mikkelsen ME et al 2010 USA 43%

Castellanos-Ortega et al 2010 Spain 34% 40%

Flavia R et al 2010 Brazil 9%

Levy MM et al 2010 USA 22% 26%

Vesteinsdotir E et al 2011 Iceland 35% 45%

Shiramizo SCPL et al 2011 Brazil 14% 44%

Tromp M et al 2011 Netherlands 27% 25%

Phua J et al 2011 Asia 8% 4%

Rinaldi L et al 2012 Italy 50 % 52% 39%

Wang Z et al 2013 China 1% 9%

Reported compliance rates with SSC bundles

These recommendations highlight the fact that the GRADE system, though transparent, is still subjective - the recommendations depend greatly on the values and preferences of the committee members.

Developers are allowed to make strong recommendations when the quality of evidence is weak, or weak recommendations when the quality of evidence is strong

Among the limitations of the guideline is the fact thatit attempts to include nearly every aspect of critical care potentially related to sepsis, perhaps losing focus in the process.

The guidelines also emphasize ‘bundles’ of care for sepsis resuscitation, although the evidence behind some of the bundled recommendations is not strong, e.g., CVP.

Already, these bundles are being turned into quality measures on which sepsis care providers will be benchmarked, even though clinicians may validly disagree with some of the recommendations.

CO = 12-15 L/min SVR = 400-500 ITBVI = 1200 ml/m2 (800-1000)

EVLW = 19-23 ml/kg (~7)

BP 70/40 mmHg

HR 155 bpm

CVP 5 cmH2O

PaO2/FiO2 80 (PEEP 16)

Low!!!

High!!!

High!!!

High!!!

Would you give fluids to this patient?

A patient with head injury, severe ARDS and septic shock

Noradrenaline + aggressive diuresis!

X

Can this patient “afford” the price of a possible mistake?

Some consensus statements are being turned into performance measures and other tools to critique the quality of physician care.

Are you compliant?

More than 80% of trauma centers that treat

mostly minority uninsured patients have

higher death rates than do trauma centers

that treat mostly white and insured patients.