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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Universitätsmedizin Mannheim
Sponsor:
Information provided by (Responsible Party):
Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT01535534
First received: February 14, 2012
Last updated: November 22, 2016
Last verified: November 2016

February 14, 2012
November 22, 2016
January 2012
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Complete list of historical versions of study NCT01535534 on ClinicalTrials.gov Archive Site
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Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Peripheral blood samples
Probability Sample
Patients suffering from sepsis
Sepsis
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Behnes M, Bertsch T, Lepiorz D, Lang S, Trinkmann F, Brueckmann M, Borggrefe M, Hoffmann U. Diagnostic and prognostic utility of soluble CD 14 subtype (presepsin) for severe sepsis and septic shock during the first week of intensive care treatment. Crit Care. 2014 Sep 5;18(5):507. doi: 10.1186/s13054-014-0507-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
July 2017
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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
Both
18 Years to 90 Years   (Adult, Senior)
Yes
Germany
 
NCT01535534
2011-384N-MA
No
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Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim
Universitätsmedizin Mannheim
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Principal Investigator: Ursula Hoffmann, MD Universitätsmedizin Mannheim
Study Director: Michael Behnes, MD Universitätsmedizin Mannheim
Universitätsmedizin Mannheim
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP