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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 February 2012 by Universitätsmedizin Mannheim
Sponsor:
Information provided by (Responsible Party):
Dr. med. Ursula Hoffmann, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT01535534
First received: February 14, 2012
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

Resource links provided by NLM:


Further study details as provided by Universitätsmedizin Mannheim:

Biospecimen Retention:   Samples Without DNA

Peripheral blood samples


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients suffering from sepsis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535534

Locations
Germany
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
Investigators
Principal Investigator: Ursula Hoffmann, MD Universitätsmedizin Mannheim
Study Director: Michael Behnes, MD Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Dr. med. Ursula Hoffmann, Principal Investigator, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT01535534     History of Changes
Other Study ID Numbers: 2011-384N-MA
Study First Received: February 14, 2012
Last Updated: February 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsmedizin Mannheim:
sepsis
inflammation
diagnosis
prognosis
survival
mortality

Additional relevant MeSH terms:
Inflammation
Sepsis
Toxemia
Infection
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 20, 2014