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
Past President, SCCM
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.
Crit Care Med. 2013; 41:580-637
Intensive Care Medicine 2013; ..
Current Surviving Sepsis Campaign Guideline Sponsors
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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
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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
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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 sepsis-induced 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.
2.
3.
4.
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Measure lactate level
Obtain blood cultures prior to administration of antibiotics
Administer broad spectrum antibiotics
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.
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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, What’s 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
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Efforts to just treat recognized sepsis alone are incomplete
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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.
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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]
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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
B
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 Patient’s Point of View
• Despite a provider’s 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 CMS’s value based purchasing metrics.
QUESTIONS?