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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
Sponsor:
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date October 17, 2006
First Posted Date October 18, 2006
Last Update Posted Date October 18, 2006
Study Start Date January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)
Official Title Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • SIRS
  • Sepsis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: October¬†17,¬†2006)
300
Original Enrollment Same as current
Study Completion Date December 2006
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00389337
Other Study ID Numbers KF01-108/04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Hvidovre University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Kristian Kofoed, MD Copenhagen Unversity Hospital Hvidovre
PRS Account Hvidovre University Hospital
Verification Date October 2006