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 (MICU) 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 MICU of an academic, tertiary-care medical center. Patients 442 consecutive patients admitted over a 4 month period who met modified SIRS criteria in a MICU. Intervention Patients were randomized to monitoring by an electronic “Listening Application” to detect modified (SIRS) criteria vs. usual care. The Listening Application notified physicians in real-time when modified SIRS 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 whether comparing among all patients (6.0h vs 6.1h, p=0.95), patients with sepsis (5.3h vs. 5.1h; p=0.90), patients on antibiotics at enrollment (5.2h vs. 7.0h, p= 0.27), or patients not on antibiotics at enrollment (5.2h vs. 5.1h, p= 0.85). The amount of fluid administered following detection of modified SIRS criteria was similar between groups whether comparing all patients or only patients hypotensive at enrollment. Other clinical outcomes including ICU length of stay, hospital length of stay, and mortality were not shown to be different between patients in the intervention and control groups. Conclusions Real-time alerts of modified SIRS criteria to physicians in one tertiary care MICU were feasible and safe but did not influence measured therapeutic interventions for sepsis or significantly alter clinical outcomes.

Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial

“…Our study used MAKE30, a patient-centered outcome recommended for phase III trials by the National Institute of Diabetes and Digestive and Kidney Diseases workgroup on Clinical Trials in AKI (18,20,34). Finally, although previous studies have examined informatics-based interventions (35)(36)(37) or leveraged the EHR to facilitate aspects of trial conduct (37)(38)(39), to our knowledge, this is the first large, critical care clinical trial to be conducted entirely within the EHR. By successfully enrolling nearly 1,000 critically ill adults, accurately delivering the assigned intervention in a time-sensitive manner, and collecting detailed data on patient characteristics, fluid receipt, laboratory values, and clinical outcomes, SALT demonstrated that the EHR-embedded clinical trial (13,14,40) is a powerful new tool for generating evidence to guide clinical practice in critical care.…”

AME evidence series 001—The Society for Translational Medicine: clinical practice guidelines for diagnosis and early identification of sepsis in the hospital

“…Two studies employed recursive partitioning tree analysis involving a variety of variables such as shock index, mean arterial blood pressure, international normalized ratio (INR), white blood cell (WBC) count, absolute neutrophil count, bilirubin, albumin, hemoglobin and sodium (74,75). One high-quality RCT, however, failed to identify any beneficial effect of this alerting system on patient-important outcomes (67). Up to now, AeSAS have only poor to moderate diagnostic performance and no beneficial effect on mortality risk and length of ICU stay.…”

“…Advances in electronic medical system technology and sophisticated machine learning techniques will "upgrade" prediction models making them more accurate and individualized (64)(65)(66). AeSAS employs two or more SIRS criteria as alert threshold (67)(68)(69)(70). Other studies use additional threshold such as SBP (71), and a lactic acid concentration >2 mmol/L (72,73).…”

Diagnostic Performance of Electronic Syndromic Surveillance Systems in Acute Care

“…Nineteen studies were retrospective in design, while 13 were prospective, nonrandomized studies. One study was a prospective randomized controlled trial [12] (▶ Table 2). …”