Alterations of Immunologic Mediators During Severe Sepsis (LAVISS_01)

February 7, 2017 updated by: Armin Sablotzki, MD, Klinikum St. Georg gGmbH
Severe sepsis induces significant changes in expression of insulin- and toll-like receptors, cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04129
        • Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with early stage of severe sepsis and septic shock

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum St. Georg gGmbH

Collaborators

University of Halle Medical Faculty

Investigators

  • Principal Investigator: Armin R Sablotzki, MD, Klinikum St. Georg gGmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISRCTN34508816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Sepsis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe