Faculty

Mitchell M. Levy, MD, FCCM

Professor of Medicine and Division
Chief
Alpert Medical School of Brown
University
Medical Director, MICU
Rhode Island Hospital
Providence , Rhode Island
Author 2004, 2008 & 2012 SSC
Guidelines
SCCM SSC Executive and Steering
Committees

Starting the Clock:

Time Zero
Considerations
Mitchell M. Levy, MD, FCCM
Brown University
Providence, RI

Funded by a grant from the

Gordon and Betty Irene
Moore Foundation

Surviving Sepsis Campaign: International guidelines for

management of severe sepsis and septic shock: 2012
R. Phillip Dellinger, Mitchell M. Levy, Andrew
Rhodes, Djillali Annane, Herwig Gerlach,
Steven M. Opal, Jonathan E. Sevransky,
Charles L. Sprung, Ivor S. Douglas, Roman
Jaeschke, Tiffany M. Osborn, Mark E.
Nunnally, Sean R. Townsend, Konrad
Reinhart, Ruth M. Kleinpell, Derek C. Angus,
Clifford S. Deutschman, Flavia R.
Machado,Gordon D. Rubenfeld, Steven A.
Webb, Richard J. Beale, Jean-Louis Vincent,
Rui Moreno, and the Surviving Sepsis
Campaign Guidelines Committee including
the Pediatric Subgroup.

Current Surviving Sepsis Campaign Guideline

Sponsors

American Association of Critical-Care

Nurses
American College of Chest Physicians
American College of Emergency
Physicians
Australian and New Zealand
Intensive Care Society
Asia Pacific Association of Critical
Care Medicine
American Thoracic Society
Brazilian Society of Critical
Care(AIMB)
Canadian Critical Care Society
Chinese Society of Critical Care
Medicine
Emirates Intensive Care Society
European Respiratory Society
European Society of Clinical
Microbiology and Infectious Diseases
European Society of Intensive Care
Medicine
European Society of Pediatric and
Neonatal Intensive Care
Infectious Diseases Society of
America

Indian Society of Critical Care Medicine

International Pan Arab Critical Care Medicine
Society

Japanese Association for Acute Medicine

Japanese Society of Intensive Care Medicine

Pediatric Acute Lung Injury and Sepsis

Investigators

Society Academic Emergency Medicine

Society of Critical Care Medicine

Society of Hospital Medicine

Surgical Infection Society

World Federation of Critical Care Nurses

World Federation of Pediatric Intensive and

Critical Care Societies

World Federation of Societies of Intensive and

Critical Care Medicine
Participation and endorsement:
German Sepsis Society
Latin American Sepsis Institute

Time Zero
Time Zero = time of presentation
ED, Medical Floors, ICU
Both bundles time based
Most important time based elements:
Antibiotic timing
Resuscitation timing (EGDT)

Antibiotic therapy
1. We recommend that intravenous
antimicrobial therapy be started as
early as possible and within the first
hour of recognition of septic shock
(1B) and severe sepsis without
septic shock (grade1C).

Hospital Mortality by Time to

Antibiotics

Fluid therapy
4. We recommend that initial fluid
challenge in patients with sepsisinduced tissue hypoperfusion with
suspicion of hypovolemnic be started
with 1000 mL of crystalloids (to
achieve a minimum of 30ml/kg of
crystalloids in the first 4 to 6 hours).
(Grade 1B).

Logistic Regression Model

SSC/NQF Bundle: Sepsis 0500

TO BE COMPLETED WITHIN 3 HOURS OF TIME OF
PRESENTATION :
1. Measure lactate level
2. Obtain blood cultures prior to administration of
antibiotics
3. Administer broad spectrum antibiotics
4. Administer 30ml/kg crystalloid for hypotension or lactate
4mmol/L

time of presentation is defined as the time of triage in

the Emergency Department or, if presenting from
another care venue, from the earliest chart annotation
consistent with all elements severe sepsis or septic shock
ascertained through chart review.

SSC/NQF Bundle: Sepsis 0500

TO BE COMPLETED WITHIN 6 HOURS OF TIME OF
PRESENTATION:
5.
6.

7.
*

Apply vasopressors (for hypotension that does not

respond to initial fluid resuscitation to maintain a mean
arterial pressure (MAP) 65mmHg)
In the event of persistent arterial hypotension despite
volume resuscitation (septic shock) or initial lactate 4
mmol/L (36mg/dl):
- Measure central venous pressure (CVP)*
- Measure central venous oxygen saturation (ScvO2)*
Remeasure lactate*
Targets for quantitative resuscitation included in the
guidelines are CVP of 8 mm Hg, ScvO2 of 70% and
lactate normalization.

So, Whats the Issue?

Many groups, especially ED physicians advocate for

alternative time zero
Time of diagnosis
Physician-based
Chart based
Labs
VS
Not all patients admitted from ED with severe sepsis present
at triage with severe sepsis
Deteriorate in ED over hours
Triage time may not reflect true time zero of severe sepsis
for all patients admitted to ICU from ED

Implications for Time Zero

New York State DOH

Mandated reporting of sepsis outcomes
Adherence to evidence-based protocols
NQF sepsis measures
Recently approved
Appeal issued by ACCP/ACEP
Fear of being dinged for patients who did not meet
criteria on triage
in ED
Public reporting
Pay for Performance

Alternatives to Triage Time

as Time Zero

We considered several sources in making our conclusions:

Comments and concerns from other organizations
represented on the 2012 SSC Guidelines Committee
Experts on the Infectious Disease Steering Committee of
the National Quality Forum (NQF)
Public comments during NQF consensus measures
process
SSC list serve discussion

Time Zero Determination: A

Balancing Act
Time zero needs to offer the best balance of :
reliability and reproducibility
optimizing the overall performance
improvement effort as to:
1. early diagnosis
2. appropriate treatment of severe sepsis.

The Importance of Early

Detection

Efforts to just treat recognized sepsis alone are incomplete

A critical aspect of mortality reduction in the Campaign has been pushing

practitioners to identify sepsis early.
Levy MM, Dellinger RP, Townsend SR ,et al. The Surviving Sepsis
Campaign: Results Of An International Guideline-Based Performance
Improvement Program Targeting Severe Sepsis. Crit Care Med. 2010
Feb;38(2):367-74.

It may well be that earlier recognition accounts for much of the signal in
mortality reduction and partially explains sharply increasing incidence.
Gaieski DF, Edwards JM, Kallan MJ, et al. Benchmarking the Incidence
and Mortality of Severe Sepsis in the United States. Crit Care Med. 2013
Feb 25. [Epub ahead of print]

Without recognition that the clock is ticking, there is simply no incentive to

recognize a challenging diagnosis early.

Using Time of Documentation is

Flawed as a Performance
Improvement Approach

Some patients will not meet severe sepsis criteria on ED

arrival, however altering time zero to chart annotation by a
practitioner would:
Turn the bundle into a treatment only bundle (not a
diagnosis and treatment bundle).
Diminish practitioners incentives to identify patients at
risk based on history, symptoms and exam findings at
ED presentation.
Reduce the reliability and reproducibility of time zero.
Make data collection more onerous and costly.

Where Do The Gains Live?

A

Lead Time to Diagnosis

Delivery of Proper Treatment

Lead time to Diagnosis & Treatment

Could a fair criterion for time zero

be onset of hypotension, with all
previous blood pressures in the ED
recorded as normotensive?

Such a time would:

falsely penalize sites for initiation of treatment prior to

the onset of hypotension.
Fluids given first? Abx given first? Blood cultures
already sent?
falsely decrease the number of observed cases meeting
severe sepsis criteria.
diminish awareness of organ dysfunction other than
hypotension.
not be the therapy that you want your loved one to
receive

Fairness and the Bell Curve

Many discussions will be had about the fairness of making

providers responsible for signs & symptoms that may not be
initially present.

Such a viewpoint presupposes the veracity of the notion that

the patient truly presented acutely to the ED for some other
reason than impending quantifiable severe sepsis/shock.
Really??? Does that meet the test of most of the time for
most cases???

Time zero as triage will lead to earlier and more frequent

recognition increased total number patients with
improved outcomes.

Long ED stays are another real quality problem and one that
hospitals should separately solve. CMS already measures
this problem and there is no persuasive reason to confuse
the issues.

The Patients Point of View

Despite a providers true
occasional inability to achieve the
time sensitive indicators:
due to late onset of symptoms
due to long elapsed time in the ED

Early detection and treatment of

my health problem is preferable.

Strategies and Rational for

Proceeding in the Next Phase of
Sepsis
Quality
Improvement
Continue to use triage time as time zero in cases presenting
to the ED.

Maximize the bundles effectiveness for diagnosis as well as

treatment.

Acknowledge a percentage of patients will not meet criteria

for severe sepsis or septic shock at ED triage and may miss
the bundle.

Recognize that whatever compliance can be achieved will be

converted to percentiles of performance by CMS for
benchmarking.

Acknowledge that benchmarked performance even at

possibly low levels of average raw compliance will still have
a top decile; the decile determines compensation in CMSs
value based purchasing metrics.

QUESTIONS?