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May - 2017

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Time to Treatment and Mortality during Mandated Emergency Care for Sepsis

C Seymour, F Gesten, H Prescott, et al New Eng J Med, 2017, online first May

Comment

In 2013, New York began requiring hospitals to follow protocols for the early identification and treatment of sepsis.  Although protocols could be tailored by each hospital, all

the protocols were required to include a;

  • 3-hour bundle consisting of receipt of the following care within 3 hours: 
    • a blood culture before the administration of antibiotics
    • measurement of serum lactate
    • administration of broad-spectrum antibiotics. 
  • 6-hour bundle, consisting of;
    • administration of a bolus of 30 ml/kg  of intravenous fluids in patients with hypotension or a serum lactate level o>= 4.0 mm/l
    • initiation of vasopressors for refractory hypotension
    • remeasurement of serum lactate level within 6 hours after the initiation of the protocol.

What effect did this mandated care have?

This retrospective study examined patient level data from the NYSDOH database  of patients with sepsis and septic shock, for 185 hospitals from 1st April 14 to 30th June 16. They looked at patients with community acquired sepsis, and 3-hour bundle initiated within 6 hours of arrival in ED. They excluded outliers who did not have 3-hr protocol completed by 12-hours. They report:

  • 83% of 49,331 eligible patients had 3-hour bundle completed within 3 hours
  • median time to completion of the 3-hour bundle was 1.30 hours
  • median time to broad-spectrum antibiotics was 0.95 hours, 30 ml/kg fluid 2.56 hours
  • mulitvariate analysis revealed each hour of time to completion of 3-hour bundle was associated with higher mortality (OR death 1.04 per hour, 95% CI 1.02-1.05, p<0.001)
  • bundle completion for the period hours 3-12 had 14% increased odds of in-hospital death
  • these results were similar for antibiotics alone (odds of death per hour and for 3-12 hrs)
  • these associations appeared to be stronger among patients receiving vasopressors
  • in patients that had IV fluids completed, time to completion of IV fluids in the first 12 hours was not associated with altered odds of mortality 

Overall this large database study reports high levels of compliance with the mandated sepsis bundle in NYC, and an association between earlier 3-hour bundle delivery and survival. The authors believe the lack of association between timing of fluid administration and survival should be interpreted with caution, as this is most open to confounding,  clinicians will give sicker patients fluid quicker. They conclude that if the relationship between timing of delivery of the bundle and survival is causal, then prompt recognition and faster treatment of sepsis may save lives. This seems reasonable.

It would have been a fascinating addition to this analysis if data preceding the 2013 bundle was obtained. If a baseline audit period had been conducted, we would have seen if mandated care results in changes in recognition of sepsis, delivery of the components, and outcome. 

 

Abstract

BACKGROUND

In 2013, New York began requiring hospitals to follow protocols for the early identification and treatment of sepsis. However, there is controversy about whether more rapid treatment of sepsis improves outcomes in patients.

METHODS

We studied data from patients with sepsis and septic shock that were reported to the New York State Department of Health from April 1, 2014, to June 30, 2016. Patients had a sepsis protocol initiated within 6 hours after arrival in the emergency department and had all items in a 3-hour bundle of care for patients with sepsis (i.e., blood cultures, broad-spectrum antibiotic agents, and lactate measurement) completed within 12 hours. Multilevel models were used to assess the associations between the time until completion of the 3-hour bundle and risk-adjusted mortality. We also examined the times to the administration of antibiotics and to the completion of an initial bolus of intravenous fluid.

RESULTS

Among 49,331 patients at 149 hospitals, 40,696 (82.5%) had the 3-hour bundle completed within 3 hours. The median time to completion of the 3-hour bundle was 1.30 hours (interquartile range, 0.65 to 2.35), the median time to the administration of antibiotics was 0.95 hours (interquartile range, 0.35 to 1.95), and the median time to completion of the fluid bolus was 2.56 hours (interquartile range, 1.33 to 4.20). Among patients who had the 3-hour bundle completed within 12 hours, a longer time to the completion of the bundle was associated with higher risk-adjusted in hospital mortality (odds ratio, 1.04 per hour; 95% confidence interval [CI], 1.02 to 1.05; P<0.001), as was a longer time to the administration of antibiotics (odds ratio, 1.04 per hour; 95% CI, 1.03 to 1.06; P<0.001) but not a longer time to the completion of a bolus of intravenous fluids (odds ratio, 1.01 per hour; 95% CI, 0.99 to 1.02; P = 0.21).

CONCLUSIONS

More rapid completion of a 3-hour bundle of sepsis care and rapid administration of antibiotics, but not rapid completion of an initial bolus of intravenous fluids, were associated with lower risk-adjusted in-hospital mortality.

May


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