Endotoxin in Gram-negative Septic Shock
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| ClinicalTrials.gov Identifier: NCT01602354 |
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Recruitment Status : Unknown
Verified June 2012 by Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was: Recruiting
First Posted : May 21, 2012
Last Update Posted : June 28, 2012
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| Condition or disease |
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| Gram Negative Septic Shock |
Medical literature states that Endotoxin (a structural molecule of the Gram-negative bacteria extracellular membrane) is able to activate target cells such as macrophages and neutrophils, inducing them to produce and release cytokine, nitric oxide and other mediators that cause a systemic inflammatory response that can evolve until to endothelial damage, shock and multi-organ failure (MOF).
Since 2004 it has been possible to better determine the concentration and the activity of endotoxin in plasma, thanks to a reliable and quick to implement method: the EAA (Endotoxin Activity Assay) test, which is an alternative technique for detecting endotoxin in whole blood based on the detection of enhanced respiratory burst activity in neutrophils following their priming by complexes of endotoxin and a specific anti-endotoxin antibody. The EAA shows excellent performance characteristics in recovering endotoxin from spiked samples and can be performed within 30 min, using less than 100µl whole blood.
Participants of this study (all affected by gram-negative septic shock) will show different values of endotoxin in their blood samples during their stay in Intensive Care Unit (ICU), and the investigators will try to figure out if these values and their trends can be somehow predictive of morbility and/or mortality, despite the small number of septic patients and the heterogeneity of their clinical picture.
So, if endotoxin induces sepsis, can the investigators also state that high values and/or trends of endotoxin can be correlated to severity of disease?
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock |
| Study Start Date : | April 2012 |
| Estimated Primary Completion Date : | June 2013 |
| Estimated Study Completion Date : | July 2013 |
| Group/Cohort |
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Gram-negative Septic shock
Patients affected by Gram-negative septic shock
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- Level of Endotoxin in blood samples [ Time Frame: admission date (baseline) ]Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
- Change of Endotoxin from baseline [ Time Frame: 3 days after admission ]Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
- Change of Endotoxin from baseline [ Time Frame: 7 dayf after admission ]Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- diagnosis of severe sepsis or septic shock
- acquisition of informed consent
- age over 18 years old
Exclusion Criteria:
- any diagnosis different from severe sepsis or septic shock
- rejection of informed consent by participant
- age under 18 years old
- any clinic condition considered not suitable by researcher
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602354
| Italy | |
| Department of Intensive Care Unit, AOU Pisana | Recruiting |
| Pisa, Italy, 56100 | |
| Contact: Francesco Forfori, Researcher forforiden@libero.it | |
| Contact: Imma Tatiana Borrelli, Doctor tatiana_borrelli@yahoo.it | |
| Principal Investigator: Imma Tatiana Borrelli, Doctor | |
| Principal Investigator: Francesco Forfori, Researcher | |
| Study Director: | Francesco Forfori, Researcher | Department of Intensive Care Unit, Azienda Ospedaliero-Universitaria (AOU) Pisana | |
| Study Chair: | Francesco Giunta, Professor | Depatment of Intensive Care Unit, AOU Pisana | |
| Principal Investigator: | Imma Tatiana Borrelli, Doctor | Department of Intensive Care Unit, AOU Pisana |
| Responsible Party: | Imma Tatiana Borrelli, Principal Investigator, Azienda Ospedaliero, Universitaria Pisana |
| ClinicalTrials.gov Identifier: | NCT01602354 History of Changes |
| Other Study ID Numbers: |
EAA G- SEP |
| First Posted: | May 21, 2012 Key Record Dates |
| Last Update Posted: | June 28, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana:
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Endotoxin Activity Assay Gram negative Septic Shock EAA |
Additional relevant MeSH terms:
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Shock Shock, Septic Pathologic Processes Sepsis |
Infection Systemic Inflammatory Response Syndrome Inflammation |