Endotoxin in Gram-negative Septic Shock
Recruitment status was Recruiting
The purpose of this observational study is to determine whether endotoxin levels and/or their trends can be considered predictive of morbility or mortality in septic shock caused by gram-negative bacteria, searching also for a possible correlation with Simplified Acute Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells (WBC) and Platelets (PLT).
Gram Negative Septic Shock
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock|
- Level of Endotoxin in blood samples [ Time Frame: admission date (baseline) ] [ Designated as safety issue: No ]Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
- Change of Endotoxin from baseline [ Time Frame: 3 days after admission ] [ Designated as safety issue: No ]Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
- Change of Endotoxin from baseline [ Time Frame: 7 dayf after admission ] [ Designated as safety issue: No ]Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
Biospecimen Retention: Samples With DNA
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Gram-negative Septic shock
Patients affected by 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?
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602354
|Department of Intensive Care Unit, AOU Pisana||Recruiting|
|Pisa, Italy, 56100|
|Contact: Francesco Forfori, Researcher firstname.lastname@example.org|
|Contact: Imma Tatiana Borrelli, Doctor email@example.com|
|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|