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
  Purpose

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
SIRS
Sepsis

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Estimated Enrollment: 300
Study Start Date: January 2005
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389337

Locations
Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark, DK2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Kristian Kofoed, MD Copenhagen Unversity Hospital Hvidovre
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00389337     History of Changes
Other Study ID Numbers: KF01-108/04
Study First Received: October 17, 2006
Last Updated: October 17, 2006
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
Sepsis
SIRS
Biomarkers
xMAP

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 21, 2014