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

February 14, 2012 updated by: Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim
Aims of the study were to find vascular markers of inflammation and endothelial damage during the course of severe sepsis in septic patients and the effects of treatment with anti-inflammatory medication (such as Drotregocin alfa (activated)). Another aim is to find new markers and gene polymorphisms for prognosis and mortality of patients with severe sepsis. The hypothesis is that higher plasma concentrations of certain markers in septic patients are associated with a higher mortality rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Human activated protein C (Drotrecogin alfa (activated)), an important coagulation inhibitor plays a major role in regulating microvascular coagulation, inflammation and immunology. Little is known about prognostic vascular biomarkers during the time course of patients with severe sepsis.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mannheim
      • University hospital Mannheim, Mannheim, Germany, 68167
        • 1. Medical Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New Prognostic markers for septic patients
Time Frame: until 300 Patients are included
until 300 Patients are included

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Ursula Hoffmann, MD, First Department of Medicine, University Medical Centre Mannheim
  • Study Chair: Michael Behnes, MD, University Medical Centre Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 16, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nr.0244.4_1
  • 0244.4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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