Alterations of immunologic mediators during severe sepsis
| ISRCTN | ISRCTN34508816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34508816 |
| ClinicalTrials.gov (NCT) | NCT00484146 |
| Protocol serial number | LAVISS_01 |
| Sponsor | Urban Clinical Center of St Georg in Leipzig (Städt. Klinikum St. Georg, Leipzig) (Germany) |
| Funder | Urban Clinical Center of St Georg in Leipzig (Städt. Klinikum St. Georg Leipzig) (Germany) |
- Submission date
- 20/04/2006
- Registration date
- 13/06/2006
- Last edited
- 01/02/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Armin Sablotzki
Scientific
Scientific
Delitzscher Str. 141
Leipzig
04129
Germany
| Phone | +49 (0)341 909 2570 |
|---|---|
| armin.sablotzki@sanktgeorg.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective, open, clinical observational study |
| Secondary study design | Cohort study |
| Scientific title | Alterations of immunologic mediators during severe sepsis |
| Study objectives | 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(s) | Ethics approval received from the Ethics Committee of the Saxonian Chamber of Physicians on the 21st July 2006 (ref: EK-BR-15/06-1). |
| Health condition(s) or problem(s) studied | Severe sepsis |
| Intervention | Daily blood samples for 7 days |
| Intervention type | Other |
| Primary outcome measure(s) | Alterations of immunologic parameters |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 31/12/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Delitzscher Str. 141
Leipzig
04129
Germany
04129
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
01/02/2019: Clinicaltrials.gov states that this trial was terminated by October 2012 due to low accrual
