Sepsis is one of the most frequent reasons for referral to emergency departments (EDs)
worldwide. The incidence of sepsis is likely to rise in the upcoming years. Sepsis has a
tendency to become more serious when left untreated with a high mortality rate, exceeding
even those of myocardial infarction and stroke. Therefore, much effort has been put in to
start with appropriate therapy as early as possible. Early goal-directed therapy (EGDT) in
the emergency department with fluid resuscitation, administration of
vasopressors/vasodilators and intravenous antibiotics in patients with severe sepsis and
septic shock has indeed decreased mortality substantially. Emergency medical services (EMS)
personnel have already made a significant difference in improving care for patients with
acute coronary syndrome, multiple trauma and stroke. Patients with severe sepsis or septic
shock could also benefit greatly from timely pre-hospital care. Earlier recognition and
initiation of treatment by EMS personnel may improve survival even more.
Interestingly, the first hour of ED presentation seems to be the most critical hour.
Administration of antibiotics and fluid resuscitation in the pre-hospital setting will reduce
the time to administration substantially. In adults, to the best of our knowledge, no studies
on the effect of pre-hospital administration of antibiotics have been performed. In children
with meningitis, some uncontrolled studies show contradictory results, most probably due to
bias by severity. We propose a non-blinded randomised multicentre clinical trial study on the
efficacy of early, pre-hospital intravenous administration of broad spectrum antibiotics
(ceftriaxone), which are effective against a wide variety of infectious pathogens that cause
most common community-acquired infections) in patients referred to the ED with suspected
severe sepsis or septic shock.
Objective: To evaluate whether early, pre-hospital administration of antibiotics, together
with training of ambulance personnel in recognizing and initiating treatment reduces 28-day
mortality in patients referred to the ED with suspected severe sepsis or septic shock
Study design: Non-blinded randomized multicentre clinical trial nested within a stepped wedge
design
Study population: All patients above the age of 18 years, with suspected severe sepsis or
septic shock and transferred to the ED by ambulance, are eligible for study inclusion
Intervention: prehospital antibiotics (ceftriaxone 2000 mg intravenously)
Main study parameters/endpoints: 28-day mortality, hospital length of stay, admission to
intensive or medium care unit (ICU/MC), time to administration of antibiotics. Follow up of
one year. QoL after one month after discharge.
Phase:
N/A
Details
Lead Sponsor:
VU University Medical Center
Collaborators:
Nederlandse Internisten Vereniging ( Dutch Association of Internists) Stichting Nuts Ohra