Impact of Early Sepsis Care Guided by the National Early Warning Score 2 in the Emergency Department - Trial NCT05731349

Timeline & Enrollment

Primary Outcome

All-cause 30-day mortality

Summary

The goal of this pilot clinical trial is to determine the feasibility of conducting a fully
 powered type 1 hybrid effectiveness-implementation trial on early sepsis care that is guided
 by early warning score in adult emergency department (ED) patients who have infection. The
 main questions it aims to answer are:
 
 - Is it feasible to execute the trial procedure and fulfill the progression criteria to a
 full-scale trial?
 
 - Does the Surviving Sepsis Campaign (SSC) Hour-1 Bundle care reduce the mortality of
 adult ED patients with a clinical diagnosis of infection and a National Early Warning
 Score 2 (NEWS2) equal to or greater than 5?
 
 - What are the barriers to and facilitators of the implementation of the SSC Hour-1 Bundle
 in the ED settings?
 
 Participants will receive the following SSC Hour-1 Bundle care during the intervention
 period:
 
 - Blood lactate level measurement
 
 - Blood cultures collection before administering antibiotics
 
 - Broad-spectrum antibiotics
 
 - Intravenous fluid
 
 - Vasopressors if the blood pressure remains low during or after fluid replacement to
 maintain the mean arterial blood pressure equal to or greater than 65 mmHg
 
 Researchers will compare patients who receive SSC Hour-1 Bundle triggered by a NEWS2 equal to
 or greater than 5 and patients who receive standard treatment based on clinical judgement to
 see if the SSC Hour-1 that is triggered by a high NEWS2 score could reduce mortality of adult
 ED patients with infection.

ICD-10 Classifications