Sepsis Clinical Trial
Official title:
Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)
BACKGROUND: In November 2003 the Medical Director at Copenhagen University Hospital,
Hvidovre, gathered a group of doctors involved in the diagnosis and treatment of patients
with sepsis.
AMIS: To develop a fast and reliable tool that can guide the physician in the diagnosis and
treatment of the septic patient thereby reducing mortality and morbidity. The measurement of
markers of inflammation, coagulation, infection and specific bacterial antigens in the same
plasma sample will give insight to the pathogenesis of sepsis and SIRS and the bodies
responds to the disease.
MATERIAL AND METHODES: Case-Control study nested in cohort. 300 patients admitted to the
hospital from 1.01.05 to 01.07.06. Copenhagen University Hospital, Hvidovre, an 800 beds
hospital, covers a part of Copenhagen with a wide variety in the population's socioeconomic
and cultural background. For the analysis of markers the luminex 100 lab analysis system is
used. It utilizes xMAP® technology which enables you to simultaneously assay up to 100
analytes in a single well of a microtiter plate, using very small sample volumes. Assay
development of a 15-plex is don In-house.
COWORKERS & FOUNDING: The following departments at the hospital, are coworkers in the SPEEDI
study: Clinical Research Unit, Departments of Infectious Disease, Clinical Microbiology,
Clinical Biochemistry, Gastroenterology (incl. surgery), Intensive Care Unit, Emergency
Room, and the Hospital Board of Directors. All departments have research experience and a
long tradition of publication of scientific works. The study received founding for equipment
and salaries during the first phase of the study from the hospitals Board of Directors.
Applications to major public foundations in Denmark are awaiting answer. No commercial
interest are involved in the study.
FUTURE APPLICATIONS: A second phase of the study including children admitted at the hospital
is in preparation. The very small sample volume is a great advantage in diagnosing infection
in children. The applications of the study results will hopefully provide the physician with
the needed tool for a fast and reliable diagnosis, prognosis and treatment guide for the
patients suffering from SIRS and sepsis.
n/a
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
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