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

This study is currently recruiting participants.

Verified February 2012 by University Hospital 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

History of Changes

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:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Further study details as provided by University Hospital 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

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

University Hospital Mannheim

Investigators

Principal Investigator:	Ursula Hoffmann, MD	University Hospital Mannheim
Study Director:	Michael Behnes, MD	University Hospital 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 University Hospital Mannheim:

sepsis
inflammation
diagnosis

prognosis
survival
mortality

Additional relevant MeSH terms:

Inflammation
Sepsis
Toxemia

Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on May 19, 2013

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