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

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. Identifier: NCT01535534
Recruitment Status : Active, not recruiting
First Posted : February 17, 2012
Last Update Posted : August 27, 2020
Information provided by (Responsible Party):
Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim

Brief Summary:
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. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.

Condition or disease

Detailed Description:

Primary Outcome Measures:

New diagnostic and prognostic markers for septic patients

Estimated Enrollment: 300 patients Study Start Date: January 2012 Estimated Study Completion Date: open Estimated Primary Completion Date: open

Intervention Details:

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

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Actual Study Start Date : January 2012
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Biospecimen Retention:   Samples Without DNA
Peripheral blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients suffering from sepsis

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 identifier (NCT number): NCT01535534

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University Medical Centre Mannheim
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
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Principal Investigator: Ursula Hoffmann, MD Universitätsmedizin Mannheim
Study Director: Michael Behnes, MD Universitätsmedizin Mannheim
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. med. Ursula Hoffmann, Principal Investigator, Universitätsmedizin Mannheim Identifier: NCT01535534    
Other Study ID Numbers: 2011-384N-MA
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Keywords provided by Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim:
Additional relevant MeSH terms:
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Pathologic Processes
Systemic Inflammatory Response Syndrome