Condition category
Infections and Infestations
Date applied
20/04/2006
Date assigned
13/06/2006
Last edited
20/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Armin Sablotzki

ORCID ID

Contact details

Delitzscher Str. 141
Leipzig
04129
Germany
+49 (0)341 909 2570
armin.sablotzki@sanktgeorg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00484146

Protocol/serial number

LAVISS_01

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval

Ethics approval received from the Ethics Committee of the Saxonian Chamber of Physicians on the 21st July 2006 (ref: EK-BR-15/06-1).

Study design

Prospective, open, clinical observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Severe sepsis

Intervention

Daily blood samples for 7 days

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Alterations of immunologic parameters

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or older
2. Agreement with study procedures, informed consent
3. Fulfilling 3 out of 4 criteria of a systemic inflammatory response syndrome (SIRS)
4. Suspected or proven infection
5. Two or more sepsis-induced organ dysfunctions
6. Start of first sepsis-induced organ dysfunction within the last 36 hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Non-agreement with study procedures
2. Sign of severe sepsis for more than 36 hours
3. Chronic immuno-compromizing diseases
4. Chronic therapy with anti-inflammatory drugs
5. Non-curable cancer diseases
6. Chronic renal failure with hemodialysis
7. Pregnant or breast feeding

Recruitment start date

01/06/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Delitzscher Str. 141
Leipzig
04129
Germany

Sponsor information

Organisation

Urban Clinical Center of St Georg in Leipzig (Städt. Klinikum St. Georg, Leipzig) (Germany)

Sponsor details

Delitzscher Str. 141
Leipzig
04129
Germany
+49 (0)341 909 2570
kais@sanktgeorg.de

Sponsor type

Hospital/treatment centre

Website

http://www.sanktgeorg.de

Funders

Funder type

Hospital/treatment centre

Funder name

Urban Clinical Center of St Georg in Leipzig (Städt. Klinikum St. Georg Leipzig) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes