A pilotstudy to clinical scorings systems and biomarkers in blood and urine of sepsis patients in the emergency care

Sepsis is a life-threatening condition with a mortality rate of 30-70%. Most
deaths are the result of multi organ failure due to systemic inflammation.
Considering the high mortality rate, it is essential to distinguish patients
that will develop severe sepsis and thus need aggressive therapy and ICU
admission. Several instruments for predicting sepsis severity have been
developed, however not many studies have compared different instruments and
therefore evidence for which instrument works best is lacking. Evaluating
biomarkers in blood and urine is a possible way to predict multi organ failure
in sepsis and thereby the need for aggressive therapy, but for which biomarker
is best, evidence is also lacking . In this pilot study we will compare three
simple sepsis severity prediction instruments and several biomarkers in blood
and urine for their ability to predict the sepsis severity in the emergency
department of the UMCG. We will also evaluate the predictive value of the
instruments for intensive care unit admission.
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The aim of this study is to determine which predictive instrument is most
reliable in predicting sepsis severity in de emergency department: the SIRS
criteria, the PIRO score or the clinical impression scale. Furthermore, we want
to determine whether a correlation exists between several biomarkers in blood
and urine and sepsis severity.

A prospective, observational pilot study with 160 patients having (suspected)
sepsis in the emergency department.

Scores derived from clinical impression score and PIRO sepsis staging score,
SIRS criteria, and relevant biomarkers in blood and urine at arrival at the
emergency department will be compared to clinical development, intensive care
unit admission, mechanical ventilation necessity, development of acute kidney
injury and mortality.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: blood and urine samples will be collected at the
emergency department. The doctor and nurse will report their clinical
impression score. The SIRS criteria and PIRO sepsis staging score will be
calculated from laboratory findings and the medical record. The burden for
subjects is minimal. In case of suspected sepsis, blood and urine samples are
routinely collected and no additional vena punction has to be performed.
The subjects will be recruited from a group of patients who will be partially
unable to give informed consent due to their condition at the moment of
admission at the emergency department. Especially subjects suffering from
septic shock may have altered consciousness. Informed consent will always be
obtained before enrolment in the pilot study, either from the patient or from a
person with the legal right to represent the patient.
The subjects will receive the same therapy as patients who do not participate
in the study. Subjects may benefit from participating in the study, because the
severity of their condition may be recognized earlier, something researchers
have proved to be of great importance for the prognosis of septic patients