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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222222
• Other study ID #: Nr.0244.4_1
• Secondary ID: 0244.4
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: February 14, 2012
• Start date: March 2003
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Procedure:
• vein puncture
comparison of different inflammatory markers in the blood of septic patients

Locations

Country	Name	City	State
Germany	1. Medical Department	University hospital Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Prognostic markers for septic patients		until 300 Patients are included	No