Alterations of Immunologic Mediators During Severe Sepsis | NCT00484146

Studies
Alterations of Immunologic Mediators During Severe Sepsis

NCT00484146

Sponsor

Klinikum St. Georg gGmbH

Status

Terminated

Last Update Posted

Feb 9, 2017Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Severe 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

ID	Type	Description	Link
ISRCTN34508816

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

anticipated number of patients could not be reached

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jun 7, 2007

First Submission Date that Met QC Criteria

Jun 7, 2007

First Posted Date

Jun 8, 2007Estimated

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 7, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Name	Class
University of Halle Medical Faculty	OTHER

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

Severe sepsis induces significant changes in expression of insulin- and toll-like receptors, cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.

Detailed Description

In patients at early stage of severe sepsis, we investigate the expression of pro- and anti-inflammatory cytokines, chemokines, adhesion-molecules, toll-like receptors, insulin-receptors, markers of apoptosis und of t- and b-cell-activation on a mRNA level.

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

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
severity of sepsis	SOFA-Score	96 hours after diagnosis of sepsis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >= 18 y
agreement with study procedures
3 of 4 SIRS-criteria
proven or highly suspected infection
2 or more sepsis-induced organ failures
start of first sepsis-induced organ failure within the last 36 hours

Exclusion Criteria:

non-agreement with study procedures
signs of severe sepsis with organ failure > 36 hours
chronic immuno-compromising diseases
chronic therapy with anti-inflammatory drugs
non-curable cancer
chronic renal failure with hemodialysis
pregnancy or breast-feeding

Accepts Healthy Volunteers

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

Patients with early stage of severe sepsis and septic shock

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin R Sablotzki, MD	Klinikum St. Georg gGmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit		Leipzig	Saxony	04129	Germany

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided