Comparing Hour-1 and 3-Hour Sepsis Treatment Bundles to Improve Survival and Respiratory Outcomes in Adults with Sepsis in the Emergency Department

What this Trial Is About

Sepsis is a leading cause of admission to intensive care units and a major cause of respiratory failure and death in these settings. Researchers are evaluating the effectiveness of two different sepsis treatment bundlesthe Hour-1 bundle versus the 3-Hour bundlein patients admitted to emergency departments with sepsis. This study uses a pragmatic, cluster-randomized design to compare the impact of these bundles on mortality and respiratory failure outcomes, while also exploring distinct sepsis patient types to enable more personalized treatment in the future. Patients enrolled in the trial will receive the same sepsis treatment bundle, which includes measuring lactate levels, obtaining blood cultures before antibiotics, administering broad-spectrum antibiotics, providing rapid fluid resuscitation, and applying vasopressors if needed. The difference between groups lies in the timing one group will have all interventions started within 1 hour, and the other within 3 hours of identification. The study employs a detailed electronic alert and navigation system to guide providers through the treatment steps and ensure timely completion. Participants will be closely monitored for outcomes such as mortality within 28 days, hospital length of stay, ventilator-free days, and respiratory failure incidence. The study collects routine clinical data to identify sepsis phenotypes and tracks adherence to treatment bundles. The total duration and follow-up depend on hospital stay and clinical progress, with continuous evaluation of patient data through automated screening tools and electronic health record methods.

Assessment for Implementation Methods in Sepsis