CClinicalTrials.gg
TerminatedNCT00484146LAVISS_01Updated Feb 9, 2017

Alterations of Immunologic Mediators During Severe Sepsis

An observational study in Severe Sepsis, sponsored by Klinikum St. Georg gGmbH. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Klinikum St. Georg gGmbH · Observational

Why this study was terminated
anticipated number of patients could not be reached
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Severe Sepsis

Browse trials for

Keywords

  • Sepsis
  • Early Stage
  • Immune System
  • Receptors
  • Cytokines
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 20 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Klinikum St. Georg gGmbH is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with early stage of severe sepsis and septic shock

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. severity of sepsis

    SOFA-Score

    Time frame: 96 hours after diagnosis of sepsis

07

Study locations

1 site
  • Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit
    Leipzig, Sachsen 04129, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00484146
Lead sponsor
Klinikum St. Georg gGmbH
Collaborators
University of Halle Medical Faculty
Responsible party
Armin Sablotzki, MD (Prof. Dr. med., Klinikum St. Georg gGmbH) — Principal investigator
First posted
Jun 8, 2007
Start date
Jun 2006
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Feb 9, 2017

Study contacts

Armin R Sablotzki, MD
principal investigator · Klinikum St. Georg gGmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion