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

NCT ID: NCT00222222

Last Updated: 2012-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2011-12-31

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.

Conditions

Sepsis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

vein puncture

comparison of different inflammatory markers in the blood of septic patients

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Ursula Hoffmann

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula Hoffmann, MD

Role: PRINCIPAL_INVESTIGATOR

First Department of Medicine, University Medical Centre Mannheim

Michael Behnes, MD

Role: STUDY_CHAIR

University Medical Centre Mannheim

Locations

1. Medical Department

University Hospital Mannheim, Mannheim, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 22973876 (View on PubMed)

Other Identifiers

0244.4

Identifier Type: -

Identifier Source: secondary_id

Nr.0244.4_1

Identifier Type: -

Identifier Source: org_study_id