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

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ClinicalTrials.gov Identifier: NCT00389337
Recruitment Status : Unknown
Verified October 2006 by Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2006
Last Update Posted : October 18, 2006
Information provided by:
Hvidovre University Hospital

Brief Summary:

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.

Condition or disease
SIRS Sepsis

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Study Type : Observational
Enrollment : 300 participants
Observational Model: Defined Population
Time Perspective: Other
Official Title: Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)
Study Start Date : January 2005
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389337

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Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark, DK2650
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Kristian Kofoed, MD Copenhagen Unversity Hospital Hvidovre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00389337    
Other Study ID Numbers: KF01-108/04
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: October 18, 2006
Last Verified: October 2006
Keywords provided by Hvidovre University Hospital:
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes