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Randomized Controlled Trial
. 2015 Aug;43(8):1595-602.
doi: 10.1097/CCM.0000000000001020.

An Electronic Tool for the Evaluation and Treatment of Sepsis in the ICU: A Randomized Controlled Trial

Matthew W Semler  1 , Liza Weavind, Michael H Hooper, Todd W Rice, Supriya Srinivasa Gowda, Andras Nadas, Yanna Song, Jason B Martin, Gordon R Bernard, Arthur P Wheeler
Affiliations
Randomized Controlled Trial

An Electronic Tool for the Evaluation and Treatment of Sepsis in the ICU: A Randomized Controlled Trial

Matthew W Semler et al. Crit Care Med. 2015 Aug.

Abstract

Objectives: To determine whether addition of an electronic sepsis evaluation and management tool to electronic sepsis alerting improves compliance with treatment guidelines and clinical outcomes in septic ICU patients.

Design: A pragmatic randomized trial.

Setting: Medical and surgical ICUs of an academic, tertiary care medical center.

Patients: Four hundred and seven patients admitted during a 4-month period to the medical or surgical ICU with a diagnosis of sepsis established at the time of admission or in response to an electronic sepsis alert.

Interventions: Patients were randomized to usual care or the availability of an electronic tool capable of importing, synthesizing, and displaying sepsis-related data from the medical record, using logic rules to offer individualized evaluations of sepsis severity and response to therapy, informing users about evidence-based guidelines, and facilitating rapid order entry.

Measurements and main results: There was no difference between the electronic tool (218 patients) and usual care (189 patients) with regard to the primary outcome of time to completion of all indicated Surviving Sepsis Campaign 6-hour Sepsis Resuscitation Bundle elements (hazard ratio, 1.98; 95% CI, 0.75-5.20; p = 0.159) or time to completion of each element individually. ICU mortality, ICU-free days, and ventilator-free days did not differ between intervention and control. Providers used the tool to enter orders in only 28% of available cases.

Conclusions: A comprehensive electronic sepsis evaluation and management tool is feasible and safe but did not influence guideline compliance or clinical outcomes, perhaps due to low utilization.

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Conflict of interest statement

Conflicts of Interest and Source of Funding: Study supported by grants 1RC1LM010310-01 from NIH, 1 UL1 RR024975 from NCRR/NIH, and CCF- 0424422 from NSF. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. M.H.H. reported prior consulting for Biomereux and T.W.R. reported serving on an advisory board for Avisa Pharma, LLC and as a DSMB member for GlaxoSmithKline. Otherwise, the authors declare no potential conflicts of interest.

Figures

Figure 1
Figure 1. Enrollment and Randomization
Of 475 patients assessed as septic, 68 had been enrolled in the study previously in the hospitalization and were excluded. The remaining 407 were randomized, followed, and included in the analysis.
Figure 2
Figure 2. Completion of Surviving Sepsis Campaign 6 hour Sepsis Resuscitation Bundle Elements for Patients Randomized to the Electronic Tool (study intervention) versus Usual Care (control)
Proportion of patients for whom indicated bundle elements were completed over the 6 hours after enrollment. Lactate measurement, CVP measurement, and antibiotic administration were considered indicated in all patients during their first 6 hours in the ICU. Blood cultures were considered indicated in all patients but deemed completed at enrollment if obtained in the 6 hours prior to enrollment. Fluid bolus administration and vasopressor administration were considered indicated only in patients who met the hemodynamic criteria for each intervention as specified in the SSC 6-hr Resuscitation Bundle. There was no difference between the electronic tool and usual care with regard to time to completion of the SSC 6-hr Resuscitation Bundle elements.
Figure 3
Figure 3. Completion of Surviving Sepsis Campaign 6 hour Sepsis Resuscitation Bundle Elements by Use of Electronic Tool for Order Entry
Proportion of patients for whom indicated bundle elements were completed over the 6 hours after enrollment for the subgroups of patients for whom the tool was used to enter orders versus patients for whom it was not used to enter orders. Lactate measurement, CVP measurement, and antibiotic administration were considered indicated in all patients during their first 6 hours in the ICU. Blood cultures were considered indicated in all patients but deemed completed at enrollment if obtained in the 6 hours prior to enrollment. Fluid bolus administration and vasopressor administration were considered indicated only in patients who met the hemodynamic criteria for each intervention as specified in the SSC 6-hr Resuscitation Bundle. Graphs in this figure display patients for whom the resuscitation bundle element was indicated during the 6 hours after enrollment and exclude patients for whom the element was completed before enrollment or not indicated. Patients for whom the tool was used to enter orders were more likely to have blood cultures obtained and lactate measured.
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Comment in

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