Faculty Mitchell M. Levy, MD, FCCM Professor of Medicine and Division Chief Alpert Medical School of Brown University Medical Director, MICU Rhode Island.

FacultyMitchell M. Levy, MD, FCCMProfessor of Medicine and Division ChiefAlpert Medical School of Brown UniversityMedical Director, MICU Rhode Island Hospital Providence , Rhode Island

Author 2004, 2008 & 2012 SSC GuidelinesSCCM SSC Executive and Steering CommitteesPast President, SCCM

Starting the Clock: Time Zero Considerations

Mitchell M. Levy, MD, FCCMBrown UniversityProvidence, RI

Funded by a grant from the Gordon and Betty Irene Moore

Foundation

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; ..

Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2012

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 MedicineParticipation and endorsement:German Sepsis SocietyLatin 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 therapy4. 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. Measure lactate level2. Obtain blood cultures prior to administration of antibiotics3. Administer broad spectrum antibiotics4. 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. Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation to maintain a mean arterial pressure (MAP) ≥65mmHg)

6. 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)*

7. 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• 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 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?