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

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ClinicalTrials.gov Identifier: NCT01535534
Recruitment Status : Recruiting
First Posted : February 17, 2012
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):

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

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
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Study Start Date : January 2012
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples Without DNA
Peripheral blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
Contacts and Locations

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): NCT01535534

University Medical Centre Mannheim Recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Contact: Ursula Hoffmann, MD    00496213832030    ursula.hoffmann@umm.de   
Contact: Michael Behnes, MD    00496213832030    michael.behnes@umm.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Principal Investigator: Ursula Hoffmann, MD Universitätsmedizin Mannheim
Study Director: Michael Behnes, MD Universitätsmedizin Mannheim
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Ursula Hoffmann, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT01535534     History of Changes
Other Study ID Numbers: 2011-384N-MA
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim:

Additional relevant MeSH terms:
Pathologic Processes
Systemic Inflammatory Response Syndrome