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

Sponsor
Universitätsmedizin Mannheim (Other)
Overall Status
Unknown status
CT.gov ID
NCT01535534
Collaborator
(none)
250
Enrollment
1
Location
119
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jan 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University Medical Centre Mannheim Mannheim Baden-Württemberg Germany 68167

      Sponsors and Collaborators

      • Universitätsmedizin Mannheim

      Investigators

      • Principal Investigator: Ursula Hoffmann, MD, Universitätsmedizin Mannheim
      • Study Director: Michael Behnes, MD, Universitätsmedizin Mannheim

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Dr. med. Ursula Hoffmann, Principal Investigator, Universitätsmedizin Mannheim
      ClinicalTrials.gov Identifier:
      NCT01535534
      Other Study ID Numbers:
      • 2011-384N-MA
      First Posted:
      Feb 17, 2012
      Last Update Posted:
      Aug 27, 2020
      Last Verified:
      Aug 1, 2020
      Keywords provided by Dr. med. Ursula Hoffmann, Principal Investigator, Universitätsmedizin Mannheim
      sepsis
      inflammation
      diagnosis
      prognosis
      survival
      mortality
      Additional relevant MeSH terms:
      Sepsis
      Toxemia
      Inflammation

      Study Results

      No Results Posted as of Aug 27, 2020