Mediators of Inflammation, Prognostic Markers and Genetic... | NCT00222222

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

NCT00222222

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Feb 16, 2012Estimated

Enrollment

105Actual

Phase

Not Applicable

Conditions

Sepsis

Interventions

vein puncture

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
0244.4

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2012

Last Update Posted Date

Feb 16, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Ursula Hoffmann, PD Dr. med., Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vein puncture	Procedure	comparison of different inflammatory markers in the blood of septic patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ursula Hoffmann, MD	First Department of Medicine, University Medical Centre Mannheim	Principal Investigator
Michael Behnes, MD	University Medical Centre Mannheim	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1. Medical Department		University Hospital Mannheim	Mannheim	68167	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22973876	Derived	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.

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis