Randomized trial of automated, electronic monitoring to facilitate early detection of sepsis in the intensive care unit*

Abstract

Objective: To determine whether automated identification with physician notification of the systemic inflammatory response syndrome in medical intensive care unit patients expedites early administration of new antibiotics or improvement of other patient outcomes in patients with sepsis.

Design: : A prospective randomized, controlled, single center study.

Setting: Medical intensive care unit of an academic, tertiary care medical center.

Patients: Four hundred forty-two consecutive patients admitted over a 4-month period who met modified systemic inflammatory response syndrome criteria in a medical intensive care unit.

Intervention: Patients were randomized to monitoring by an electronic "Listening Application" to detect modified (systemic inflammatory response syndrome) criteria vs. usual care. The listening application notified physicians in real time when modified systemic inflammatory response syndrome criteria were detected, but did not provide management recommendations.

Measurements and main results: The median time to new antibiotics was similar between the intervention and usual care groups when comparing among all patients (6.0 hr vs. 6.1 hr, p = .95), patients with sepsis (5.3 hr vs. 5.1 hr; p = .90), patients on antibiotics at enrollment (5.2 hr vs. 7.0 hr, p = .27), or patients not on antibiotics at enrollment (5.2 hr vs. 5.1 hr, p = .85). The amount of fluid administered following detection of modified systemic inflammatory response syndrome criteria was similar between groups whether comparing all patients or only patients who were hypotensive at enrollment. Other clinical outcomes including intensive care unit length of stay, hospital length of stay, and mortality were not shown to be different between patients in the intervention and control groups.

Conclusions: Realtime alerts of modified systemic inflammatory response syndrome criteria to physicians in one tertiary care medical intensive care unit were feasible and safe but did not influence measured therapeutic interventions for sepsis or significantly alter clinical outcomes.

Figure 1. Schematic Representation of the Listening Application

Upon admission to the MICU, patients were electronically monitored by the L.A. for development of modified SIRS criteria. Upon detection, patients were randomized to either the control or intervention arm. For patients randomized to the intervention arm, the L.A. generated pages and EMR notifications to physicians alerting them to the presence of modified SIRS criteria and requesting an assessment of whether or not the patient was septic. ^a If a patient was determined to be septic, then monitoring was suppressed for 7 days. After 7 days, the patient was again eligible for monitoring and notifications. Patients were only enrolled and analyzed after their first notification. ^b In the case of a patient determined NOT to be septic, monitoring was suppressed for 2 days. However, if either WBC or temperature was normal at the time of the alert and then became abnormal during the 2 days of suppression, then the rules engine allowed an additional alert to be sent to the provider. After 2 days, monitoring and notifications resumed as if the patient was new to the system. Patients were only enrolled and analyzed after their first notification.