A Prospective Randomized Controlled Trial to Investigate the Effects of Training Emergency Medical Services (EMS) Personnel in Recognizing and Initiating Treatment in the Prehospital Setting Together With Early Administration of Antibiotics for Patients Suspected of (Severe) Sepsis and Septic Shock

Introduction Sepsis is one of the most common and life-threatening diseases in the world, causing more deaths than AIDS, breast cancer and prostate cancer put together (8-10). Despite the fact that the mortality of sepsis is ten times higher than myocardial infarction and to five times higher than stroke, relatively little attention is given to sepsis (23-25). In recent years successful clinical care management pathways have been developed for patients suffering from a myocardial infarction, stroke or a trauma. Even though there is strong evidence in scientific literature to support the need for a series of time-dependent actions, for sepsis this is still not the case.

On 13 September 2012, the first ' World Sepsis Day ' was held with as main objective : 'to increase awareness for sepsis as a potentially lethal condition, which should be considered as a medical emergency ' (26). Prompt recognition and treatment are extremely important for improving survival, while patients who survive sepsis can still continue to suffer from physical or psychological symptoms. The likelihood and severity of these complications depends on a number of factors including the severity of sepsis and the length of stay in hospital stay and in ICU.

Definition Sepsis is defined as a proven or strongly suspected infection that is associated with a 'systemic inflammatory response syndrome ' (SIRS) (29,30). SIRS exists if at least two of the four criteria are met: abnormal body temperature, increased heart rate (over 90 beats per minute), increased respiratory rate (more than 20 per minute) and an abnormal white blood cell (WBC) count. There are different degrees of sepsis on the basis of severity. Sepsis may develop to severe sepsis or septic shock, if treatment is not timely initiated. Severe sepsis is defined as sepsis with failure of one or more organ systems and septic shock and severe sepsis with persistent low blood pressures despite adequate resuscitation. In particular organ failure and shock cause high mortality.

In the Netherlands, more than 10,000 patients with sepsis are admitted to a hospital annually, with an average length of stay (LOS) of 15 days. The medical costs being approximately $ 20,000 per person, the total cost of severe sepsis in the Netherlands is estimated at nearly 170 million per year (1-3).

Mortality can be very high if sepsis is not timely or adequately treated, especially among the vulnerable elderly population. The mortality rates vary from 20 to 60 percent, depending on the age and other underlying diseases such as diabetes and cancer. Even in the VUmc the mortality rates are almost up to 40%. Multiorgan failure due to sepsis and septic shock is the leading cause of death in the ICU (31,32). The incidence of sepsis has increased in recent years and it is expected that this trend will continue, partly due to the aging population and partly because of increasing numbers of immune-compromised patients who are highly susceptible to all kinds of (opportunistic) infections.