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Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222222
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 16, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim

Brief Summary:
Aims of the study were to find vascular markers of inflammation and endothelial damage during the course of severe sepsis in septic patients and the effects of treatment with anti-inflammatory medication (such as Drotregocin alfa (activated)). Another aim is to find new markers and gene polymorphisms for prognosis and mortality of patients with severe sepsis. The hypothesis is that higher plasma concentrations of certain markers in septic patients are associated with a higher mortality rate.

Condition or disease Intervention/treatment Phase
Sepsis Procedure: vein puncture Not Applicable

Detailed Description:
During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Human activated protein C (Drotrecogin alfa (activated)), an important coagulation inhibitor plays a major role in regulating microvascular coagulation, inflammation and immunology. Little is known about prognostic vascular biomarkers during the time course of patients with severe sepsis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Study Start Date : March 2003
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis


Intervention Details:
  • Procedure: vein puncture
    comparison of different inflammatory markers in the blood of septic patients


Primary Outcome Measures :
  1. New Prognostic markers for septic patients [ Time Frame: until 300 Patients are included ]


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:   Yes
Criteria

Inclusion Criteria:

  • SIRS-Criteria
  • Proven Infection
  • One sepsis-induced organ-failure
  • Adults <18 years old

Exclusion Criteria:

  • Anemia
  • Pregnancy
  • Blood donor in the last 3 month

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): NCT00222222


Locations
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Germany
1. Medical Department
University hospital Mannheim, Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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Principal Investigator: Ursula Hoffmann, MD First Department of Medicine, University Medical Centre Mannheim
Study Chair: Michael Behnes, MD University Medical Centre Mannheim
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Ursula Hoffmann, PD Dr. med., Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT00222222    
Other Study ID Numbers: Nr.0244.4_1
0244.4
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012
Keywords provided by Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim:
severe sepsis
prognostic markers
polymorphisms
SIRS
Additional relevant MeSH terms:
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Sepsis
Toxemia
Inflammation
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome