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

Primary Purpose

Sepsis

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

vein puncture

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring severe sepsis, prognostic markers, polymorphisms, SIRS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

1. Medical Department

Outcomes

Primary Outcome Measures

New Prognostic markers for septic patients

Secondary Outcome Measures

Full Information

NCT ID

NCT00222222

First Posted

September 13, 2005

Last Updated

February 14, 2012

Sponsor

Universitätsmedizin Mannheim

1. Study Identification

Unique Protocol Identification Number

NCT00222222

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitätsmedizin Mannheim

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

severe sepsis, prognostic markers, polymorphisms, SIRS

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

vein puncture

Intervention Description

comparison of different inflammatory markers in the blood of septic patients

Primary Outcome Measure Information:

Title

New Prognostic markers for septic patients

Time Frame

until 300 Patients are included

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ursula Hoffmann, MD

Organizational Affiliation

First Department of Medicine, University Medical Centre Mannheim

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Behnes, MD

Organizational Affiliation

University Medical Centre Mannheim

Official's Role

Study Chair

Facility Information:

Facility Name

1. Medical Department

City

University hospital Mannheim

State/Province

Mannheim

ZIP/Postal Code

68167

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22973876

Citation

Behnes M, Brueckmann M, Lang S, Putensen C, Saur J, Borggrefe M, Hoffmann U. Alterations of leptin in the course of inflammation and severe sepsis. BMC Infect Dis. 2012 Sep 14;12:217. doi: 10.1186/1471-2334-12-217.

Results Reference

derived

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

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