Characteristics and Outcomes Between Patients Treated with Vasopressor Therapy Before and After Randomization in the Usual Care Arm of the ProCESS Trial

Objective: Patients in septic shock may be treated initially with vasopressors as fluid resuscitation is ongoing in the emergency department (ED). The optimal timing of starting vasopressor therapy remains unclear. Using observations from a trial that studied therapies in early septic shock care, we sought to compare the characteristics and outcomes of patients who were treated with vasopressor therapy before and after randomization to explore any possible timing impacts.

Methods: We analyzed a usual care (wild type) subgroup from a multicentered, emergency department based resuscitative trial for those recognized and enrolled with early septic shock. We included patients who received vasopressor therapy, classifying them into two groups based on randomization time: vasopressor therapy before or after randomization. The primary outcome was 60-day in-hospital mortality. A multivariate Cox regression model was used to adjust for confounding.

Results: Overall, we identified 201 patients in the usual care group who met our evaluation criteria. Of these, 69 received vasopressor therapy before and 132 after randomization. The group receiving vasopressor before randomization had more chronic respiratory disease (37.7% vs. 20.5%), new mechanical ventilation (37.7% vs. 21.2%), received earlier antibiotics (88.4% vs. 73.5%), and had longer time to randomization after meeting inclusion criteria (78 min vs. 59 min). In the primary analysis, the group receiving vasopressor before randomization had the same risk of death at 60 days compared to those who received vasopressor after randomization [30.4% vs. 18.9% (HR 1.48; 95% CI, 0.78-2.83, p=0.23)]. The rate of new organ failure did not differ.

Conclusions: In this subanalysis of ED patients with early septic shock, the risk of 60-day in-hospital mortality was not different between patients who received vasopressor therapy before and after randomization.