Debate over CMS SEP-1 Fluid Requirements: Are We Majoring in the Minor?

Key Takeaways:

A 71 year-old woman weighing 59 kg presents to the ED with shortness of breath, altered mental status, and fever; her blood pressure was initially 114/72 mmHg at triage but drops precipitously to 72/51 mmHg within 1 hour of presentation. Her heart rate is recorded at 97 bpm.  Her past medical history includes hypertension, COPD, and CHF. Based on her blood pressure and a concern for sepsis, you order broad spectrum antibiotics and a 1L normal saline bolus and obtain blood cultures and lactate measurements. A fluid bolus is given within 30 minutes via LifeFlow® and her blood pressure improves to 102/57.  Lab results show that her initial serum lactate level was 4.2 mmol/L.

This patient meets the Center for Medicare & Medicaid Services (CMS) Sepsis Core Measure (SEP-1) definition of septic shock:  two SIRS criteria, suspicion of infection, one or more organ dysfunction, and hypoperfusion (lactate > 4 or continued hypotension despite fluid resuscitation). Imagine that this is your patient:  you know the SEP-1 guidelines and rules for treatment… what thoughts are going through your mind?

  • Initial lactate was high and the patient appears to be fluid responsive. Should I continue to give more IV fluids?
  • Since the patient is fluid responsive, should I order additional fluids in order to achieve the SEP-1 target of 30ml/kg within 3 hours of presentation, or should I stop fluids since the BP is normalized?
  • Patient has a history of CHF… would more fluid be detrimental?

 

This situation is a common one for emergency department and critical care clinicians. Currently, CMS requires hospitals to report on sepsis management as part of the Hospital Inpatient Quality Reporting Program. For patients with septic shock, the program mandates the following within 3 hours of presentation: measure serum lactate, obtain blood cultures, administer antibiotics, and resuscitate with 30mL/kg of crystalloid fluids. In order to be compliant, all measures must be in concordance. There is no partial credit! Furthermore, no exceptions are made for any baseline co-morbidities, other than patients with an implanted ventricular device are exempted from the 30mL/kg of fluids requirement, and obese patients can have their fluid requirements adjusted using ideal body weight. Lastly, there is no appeal process based on patient’s response to initial fluid boluses or clinicians’ documentation that additional fluid was not necessary.

Although there are no exceptions to the 30mL/kg fluid requirement, the SEP-1 quality measure is currently only used as a hospital peer-to-peer comparison tool and is not linked with any value-based payment program nor with hospital reimbursement.  However, many hospitals will accept documentation of fluid exclusion for an individual patient based on cardiac output response to a fluid challenge, presence of significant pulmonary edema, or patient deterioration in response to fluid administration.  This rigidity in the CMS SEP-1 measure has led to many questions from clinicians, such as:

  • Will there ever be an exception to the 30mL/kg bolus for patients who are fluid overloaded? We have had intubated patients develop flash pulmonary edema and pink froth coming from the endotracheal tube, yet CMS says we need to keep loading them with fluids even if their BP stabilizes. Are there any plans to address this?”1
  • “Did you say there were some cases that could pass the measure, if they did not get the 30ml/kg of fluids? Example: 500ml bolus was given, but due to fear of overload with CHF, the 30ml/kg bolus was not given. How do would you answer this measure element?”2
  • “If fluids are ordered at 30mL/kg, and a nurse’s note reflects discussion with the physician to stop fluids due to fluid overload, does the element pass?”1

 

CMS’ responses to these questions suggest that they are steadfastly sticking to the 30ml/kg requirement.  Failure to provide 30ml/kg of crystalloid fluid will result in non-compliance with the entire SEP-1 measure.1-5  However, CMS concedes that “…the measure is designed to encompass the majority [emphasis added] of severe sepsis/septic shock cases and not outlier cases. Therefore, physician discretion should continue to be used when administering crystalloid fluids.”1

Some clinicians have raised concerns about the obligatory fluid bolus mandate from the SEP-1 measure and the dearth of strong supporting evidence.6-9  Despite evidence suggesting that resuscitative fluids in patients predisposed to volume overload may be safe, we also know that fluids can cause injury when not used appropriately.10-12  Several studies have documented the harm that fluids can cause, but many times these studies are conducted in the ICU where large volumes of IV fluids are often given long after the initial resuscitation.  In contrast, the fluid resuscitation-related recommendations in the SEP-1 bundle address the early, emergent phase immediately following diagnosis.  There’s also evidence that demonstrates 30ml/kg is safe even in patients who may be at risk for being fluid overloaded. Specifically, Liu and colleagues conducted a retrospective study of sepsis bundle implementation in over 18,000 patients. In this study, patients with history of heart failure and kidney disease were noted to have decreased hospital and 30d mortality following sepsis bundle implementation.13

Debate about the fluid guidelines in the SEP-1 bundle will likely continue. Should we give 30mL/kg, 10mL/kg or 500mL? We know that even a single episode of non-sustained hypotension is associated with almost a 3x higher risk of mortality in patients with sepsis,14 and early fluid resuscitation has been proven to reduce shock and hypotension.15,16 Hence, ED clinicians play the critical role of balancing the importance of early fluid resuscitation while not predisposing patients to subsequent fluid overload.  It is up to us, the provider team, to determine what’s best for the patient.  In my practice, if I have a patient in shock, I will start with a quick, small bolus because I don’t want the patient to be hypotensive for any longer than he/she has to.  An international observational study of ICUs around the world found the median amount of fluid given during a fluid challenge was 500mL.17 A patient’s response to the initial fluid bolus can provide important clues related to diagnosis and treatment, including whether the patient could benefit from or tolerate more fluid. If response to the initial bolus is positive, I will order a second bolus.  A 10-15% increase in stroke volume or cardiac output is a target that has been discussed in the literature18 and that works well in my experience. If an early fluid bolus doesn’t provide the desired response, we can redirect and quickly order pressors while exploring other options rather than continue to indiscriminately dump more fluids into the patient.

SEP-1, like other CMS quality metrics, provides an important evidenced-based guideline, but it is not a one-size-fits all solution.   If we get paralyzed by the debate over the strength of the evidence to support 30mL/kg, we’re majoring in the minor. Instead, let’s view the fluid mandate from CMS as a call to action for an earlier, controlled fluid bolus.  Then we can use our judgment to determine what additional measures, including the option of more fluids, are optimal.

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References

  1. Albritton N, Jackson C. SEP-1 Early Management Bundle, Severe Sepsis/Septic Shock: v5.3a Measure Updates. Available at https://www.qualityreportingcenter.com/globalassets/migrated-pdf/iqr_qa-transcript_sep-1_02272018_v3_vfinal508.pdf. Accessed 6/1/2019.
  2. Jackson C, Dickerson B. SEP-1 Early Management Bundle, Severe Sepsis/ Septic Shock: v5.1 Measure Updates. Available at https://www.qualityreportingcenter.com/globalassets/oct-dec-archived-events-iqr/dec-sep-1-webinar_forcmsv2_vfinal-508c.pdf. Accessed June 1, 2019.
  3. Albritton N, Omerhodzic D, Dickerson B, Jackson C. SEP-1 Early Management Bundle, Severe Sepsis/Septic Shock: v5.5a Measure Updates and v5.0b Through v5.2b Analysis Results Questions and Answers. Available at https://www.qualityreportingcenter.com/globalassets/oct-dec-archived-events-iqr/iqr_transcript_sepv5.5aupdates_12112018_vfinal508.pdf. Accessed 6/1/2019.
  4. Albritton N, Raveendran R, Jackson C. SEP-1 Early Management Bundle, Severe Sepsis/Septic Shock: V5.4 Measure Updates. Available at https://www.qualityreportingcenter.com/globalassets/migrated-pdf/iqr_transcript_sep-1-v5.4-updates_04302018_vfinal508.pdf. Accessed June 1, 2019.
  5. Albritton N, Witt J, Jackson C. SEP-1 Early Management Bundle, Severe Sepsis/Septic Shock: v5.6a Measure Updates and FAQs. Available at https://www.qualityreportingcenter.com/globalassets/iqr2019events/iqr07162019/iqr_sepsis_webinar-transcript_07162019_vfinal508.pdf. Accessed 7/30/2019.
  6. Marik PE, Malbrain M. The SEP-1 quality mandate may be harmful: How to drown a patient with 30 mL per kg fluid! Anaesthesiol Intensive Ther. 2017;49:323-328.
  7. Faust JS, Weingart SD. The Past, Present, and Future of the Centers for Medicare and Medicaid Services Quality Measure SEP-1: The Early Management Bundle for Severe Sepsis/Septic Shock. Emerg Med Clin North Am. 2017;35:219-231.
  8. Pepper DJ, Jaswal D, Sun J, Welsh J, Natanson C, Eichacker PQ. Evidence Underpinning the Centers for Medicare & Medicaid Services’ Severe Sepsis and Septic Shock Management Bundle (SEP-1): A Systematic Review. Ann Intern Med. 2018;168:558-568.
  9. Aaronson EL, Filbin MR, Brown DF, Tobin K, Mort EA. New Mandated Centers for Medicare and Medicaid Services Requirements for Sepsis Reporting: Caution from the Field. J Emerg Med. 2017;52:109-116.
  10. Kelm DJ, Perrin JT, Cartin-Ceba R, Gajic O, Schenck L, Kennedy CC. Fluid overload in patients with severe sepsis and septic shock treated with early goal-directed therapy is associated with increased acute need for fluid-related medical interventions and hospital death. Shock. 2015;43:68-73.
  11. Acheampong A, Vincent JL. A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care. 2015;19:251.
  12. Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017;43:625-632.
  13. Liu VX, Morehouse JW, Marelich GP, Soule J, Russell T, Skeath M, et al. Multicenter Implementation of a Treatment Bundle for Patients with Sepsis and Intermediate Lactate Values. Am J Respir Crit Care Med. 2016;193:1264-1270.
  14. Marchick MR, Kline JA, Jones AE. The significance of non-sustained hypotension in emergency department patients with sepsis. Intensive Care Med. 2009;35:1261-1264.
  15. Lee SJ, Ramar K, Park JG, Gajic O, Li G, Kashyap R. Increased fluid administration in the first three hours of sepsis resuscitation is associated with reduced mortality: a retrospective cohort study. Chest. 2014;146:908-915.
  16. Leisman DE, Goldman C, Doerfler ME, Masick KD, Dries S, Hamilton E, et al. Patterns and Outcomes Associated With Timeliness of Initial Crystalloid Resuscitation in a Prospective Sepsis and Septic Shock Cohort. Crit Care Med. 2017;45:1596-1606.
  17. Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, et al. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015;41:1529-1537.
  18. Cecconi M, Parsons AK, Rhodes A. What is a fluid challenge? Curr Opin Crit Care. 2011;17:290-295.