Severe SepsisLAVISS_01NCT00484146
Alterations of Immunologic Mediators During Severe Sepsis
An observational study of Severe Sepsis, run by Klinikum St. Georg gGmbH at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with early stage of severe sepsis and septic shock
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit
Leipzig, Saxony, 04129
About this study
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.
- Conditions
- Severe Sepsis
- Keywords
- Sepsis, Early Stage, Immune System, Receptors, Cytokines
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of sepsis
SOFA-Score
Measured: 96 hours after diagnosis of sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: anticipated number of patients could not be reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum St. Georg gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Halle Medical Faculty
- Responsible party
- Principal investigator, Armin Sablotzki, MD, Klinikum St. Georg gGmbH
- Investigators
- Armin R Sablotzki, MD, Principal investigator, Klinikum St. Georg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484146
- Sponsor's protocol ID
- ISRCTN34508816
- Other IDs
- ISRCTN34508816
- Acronym
- LAVISS_01
- Status last verified
- Feb 2017
- First submitted
- 7 Jun 2007
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of Immunologic Mediators During Severe Sepsis
- ClinicalTrials.gov ID
- NCT00484146
- Acronym / sponsor ID
- LAVISS_01 / ISRCTN34508816
- Conditions
- Severe Sepsis
- Keywords
- Sepsis, Early Stage, Immune System, Receptors, Cytokines
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: anticipated number of patients could not be reached
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Klinikum St. Georg gGmbHUniversity, hospital or other
- Collaborators
- University of Halle Medical Faculty
- Study start
- Jun 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early stage of severe sepsis and septic shock
Key inclusion criteria (6 listed)
- age >= 18 y
- agreement with study procedures
- 3 of 4 SIRS-criteria
- proven or highly suspected infection
- 2 or more sepsis-induced organ failures
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
severity of sepsis
Time frame: 96 hours after diagnosis of sepsis
SOFA-Score
Results and safety
The study was stopped early (reason given: anticipated number of patients could not be reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin R Sablotzki, MD principal investigator
Klinikum St. Georg gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis, run by Klinikum St. Georg gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: anticipated number of patients could not be reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of sepsis (time frame: 96 hours after diagnosis of sepsis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.