SIRSNCT00389337
Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)
An observational study of SIRS and Sepsis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Admitted to a hopital >24 h prior to inclusion
- Antibiotic therapy initiated at a hospital >8 h prior to inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, DK2650
About this 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.
Read more
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.
- Keywords
- Sepsis, SIRS, Biomarkers, xMAP
- Medical subject headings
- Sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startJan 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SIRSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kristian Kofoed, MD, Principal investigator, Copenhagen Unversity Hospital Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389337
- Sponsor's protocol ID
- KF01-108/04
- Status last verified
- Oct 2006
- First submitted
- 17 Oct 2006
- Last updated
- 18 Oct 2006
- Results posted
- No
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. doi: 10.1186/cc5723.
PubMed 17362525
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis: Prognosis and Evaluation of Early Diagnosis and Intervention (SPEEDI Study)
- ClinicalTrials.gov ID
- NCT00389337
- Acronym / sponsor ID
- KF01-108/04
- Keywords
- Sepsis, SIRS, Biomarkers, xMAP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2006
- First posted
- 18 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted with ≧ 2 of the following 4 symptoms of SIRS:
Key exclusion criteria (2 listed)
- Admitted to a hopital >24 h prior to inclusion
- Antibiotic therapy initiated at a hospital >8 h prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2006.
- Derived from this study: PubMed 17362525Kofoed 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. doi: 10.1186/cc5723.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Kofoed, MD principal investigator
Copenhagen Unversity Hospital Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIRS and Sepsis, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00389337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2006.