Back to resultsLow-Dose Endotoxemia and the Acute Phase Response
Primary Purpose
Endotoxemia, Sepsis
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
E. Coli endotoxin
Sponsored by
About this trial
This is an interventional diagnostic trial for Endotoxemia
Eligibility Criteria
Inclusion Criteria: Healty volunteers - Exclusion Criteria: Infection 14 days prior to the trial Regular medication Present and /or former heart disease -
Sites / Locations
- Department of Intensive Care
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00197899
Brief Title
Low-Dose Endotoxemia and the Acute Phase Response
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
4. Oversight
5. Study Description
Brief Summary
The purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotoxemia, Sepsis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
E. Coli endotoxin
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healty volunteers -
Exclusion Criteria:
Infection 14 days prior to the trial Regular medication Present and /or former heart disease -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente K Pedersen, MD, DMSc
Organizational Affiliation
Department of Infectious Diseases 7641, University Hospital of Copenhagen, H:S Rigshospitalet
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dorthe H Olsen, MD
Organizational Affiliation
Department of Intensive Care, Herlev University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dorthe H Olsen, DM
Organizational Affiliation
Department of Intensive Care, Herlev University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Intensive Care
City
Copenhagen
State/Province
Copenhagen County
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Low-Dose Endotoxemia and the Acute Phase Response
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