Abstract
Usual care regarding vasopressor initiation is ill-defined. We aimed to develop a quantitative “dynamic practice” model for usual care in the emergency department (ED) regarding the timing of vasopressor initiation in sepsis. In a retrospective study of 589 septic patients with hypotension in an urban tertiary care center ED, we developed a multi-variable model that distinguishes between patients who did and did not subsequently receive sustained (>24 h) vasopressor therapy. Candidate predictors were vital signs, intravenous fluid (IVF) volumes, laboratory measurements, and elapsed time from triage computed at timepoints leading up to the final decision timepoint of either vasopressor initiation or ED hypotension resolution without vasopressors. A model with six independently significant covariates (respiratory rate, Glasgow Coma Scale score, SBP, SpO2, administered IVF, and elapsed time) achieved a C-statistic of 0.78 in a held-out test set at the final decision timepoint, demonstrating the ability to reliably model usual care for vasopressor initiation for hypotensive septic patients. The included variables measured depth of hypotension, extent of disease severity and organ dysfunction. At an operating point of 90% specificity, the model identified a minority of patients (39%) more than an hour before actual vasopressor initiation, during which time a median of 2,250 (IQR 1,200–3,300) mL of IVF was administered. This single-center analysis shows the feasibility of a quantitative, objective tool for describing usual care. Dynamic practice models may help assess when management was atypical; such tools may also be useful for designing and interpreting clinical trials.
Highlights
Sepsis and septic shock represent major public health challenges, contributing to 1 in every 2 to 3 hospital deaths in the United states [1, 2]
Critics have suggested that “liberal fluids” does not represent usual care; that the CLOVERS trial is, comparing two non-standard treatment strategies; and that it will be difficult to interpret the CLOVERS trial findings because the investigational strategies are not being compared directly against usual care [7]. Such controversy might be addressed with an objective tool for characterizing and quantifying usual care in a patient population; and such a tool, the usual care provided to one population could be directly compared against the care provided in another patient population
The training set used for usual care for vasopressor” (UCV) model development included 365 patient encounters, of which 213 were in the VP>24 group and 152 in the Non-VP group
Summary
Sepsis and septic shock represent major public health challenges, contributing to 1 in every 2 to 3 hospital deaths in the United states [1, 2]. Critics have suggested that “liberal fluids” does not represent usual care; that the CLOVERS trial is, comparing two non-standard treatment strategies; and that it will be difficult to interpret the CLOVERS trial findings because the investigational strategies are not being compared directly against usual care [7]. Such controversy might be addressed with an objective tool for characterizing and quantifying usual care in a patient population; and such a tool, the usual care provided to one population (e.g., the CLOVERS control group) could be directly compared against the care provided in another patient population (e.g., another hospital not participating in the trial, or historical controls)
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