NCT00222222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 16, 2012

Status Verified

February 1, 2012

Enrollment Period

8.8 years

First QC Date

September 13, 2005

Last Update Submit

February 14, 2012

Conditions

Sepsis

Keywords

severe sepsisprognostic markerspolymorphismsSIRS

Outcome Measures

Primary Outcomes (1)

  • New Prognostic markers for septic patients

    until 300 Patients are included

Interventions

vein puncturePROCEDURE

comparison of different inflammatory markers in the blood of septic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SIRS-Criteria
  • Proven Infection
  • One sepsis-induced organ-failure
  • Adults \<18 years old

You may not qualify if:

  • Anemia
  • Pregnancy
  • Blood donor in the last 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1. Medical Department

University Hospital Mannheim, Mannheim, 68167, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22973876DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ursula Hoffmann, MD

    First Department of Medicine, University Medical Centre Mannheim

    PRINCIPAL INVESTIGATOR

  • Michael Behnes, MD

    University Medical Centre Mannheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

March 1, 2003

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 16, 2012

Record last verified: 2012-02

Locations

DE(1)