Mediators of Inflammation, Prognostic Markers and Genetic... | NCT01535534

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

NCT01535534

Sponsor

Universitätsmedizin Mannheim

Status

Unknown status

Last Update Posted

Aug 27, 2020Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

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

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2021Estimated

First Submitted Date

Feb 14, 2012

First Submission Date that Met QC Criteria

Feb 16, 2012

First Posted Date

Feb 17, 2012Estimated

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

Aug 26, 2020

Last Update Posted Date

Aug 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Ursula Hoffmann, Principal Investigator, 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

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. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.

Detailed Description

Primary Outcome Measures:

New diagnostic and prognostic markers for septic patients

Estimated Enrollment: 300 patients Study Start Date: January 2012 Estimated Study Completion Date: open Estimated Primary Completion Date: open

Intervention Details:

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

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

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

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from sepsis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ursula Hoffmann, MD	Universitätsmedizin Mannheim	Principal Investigator
Michael Behnes, MD	Universitätsmedizin Mannheim	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Mannheim		Mannheim	Baden-Wurttemberg	68167	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28793880	Derived	Hamed S, Behnes M, Pauly D, Lepiorz D, Barre M, Becher T, Lang S, Akin I, Borggrefe M, Bertsch T, Hoffmann U. Diagnostic value of Pentraxin-3 in patients with sepsis and septic shock in accordance with latest sepsis-3 definitions. BMC Infect Dis. 2017 Aug 9;17(1):554. doi: 10.1186/s12879-017-2606-3.
25190134	Derived

ID	Term
D018805	Sepsis
D007249	Inflammation
D004194	Disease

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms