Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Hvidovre University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00389337
First received: October 17, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

October 17, 2006
October 17, 2006
January 2005
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No Changes Posted
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Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)
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.

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Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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  • SIRS
  • Sepsis
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Kofoed K, Andersen O, Kronborg G, Tvede M, Petersen J, Eugen-Olsen J, Larsen K. Use of plasma C-reactive protein, procalcitonin, neutrophils, macrophage migration inhibitory factor, soluble urokinase-type plasminogen activator receptor, and soluble triggering receptor expressed on myeloid cells-1 in combination to diagnose infections: a prospective study. Crit Care. 2007;11(2):R38.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2006
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Inclusion Criteria:

  • Patients admitted with ≧ 2 of the following 4 symptoms of SIRS:

    • Resp. rate > 20/min
    • Heart rate > 90/min
    • Temperature > 38ºC or <36ºC
    • Leukocytes >12.000 or <4.000

Exclusion Criteria:

  • Admitted to a hopital >24 h prior to inclusion
  • Antibiotic therapy initiated at a hospital >8 h prior to inclusion
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00389337
KF01-108/04
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Hvidovre University Hospital
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Principal Investigator: Kristian Kofoed, MD Copenhagen Unversity Hospital Hvidovre
Hvidovre University Hospital
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP