Clinical trial NCT01602354: Endotoxin in Gram-negative Septic Shock
Official title: Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gram Negative Septic Shock
Keywords: Endotoxin Activity Assay
Gram negative
Septic Shock
EAA
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Intensive Care Unit with a diagnosis of severe sepsis or septic shock

Brief summary: 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).

Detailed description: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Level of Endotoxin in blood samples
timeFrame: admission date (baseline)
measure: Change of Endotoxin from baseline
timeFrame: 3 days after admission
measure: Change of Endotoxin from baseline
timeFrame: 7 dayf after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Department of Intensive Care Unit, AOU Pisana
Study officials:
affiliation: Department of Intensive Care Unit, Azienda Ospedaliero-Universitaria (AOU) Pisana
name: Francesco Forfori, Researcher
role: STUDY_DIRECTOR
affiliation: Depatment of Intensive Care Unit, AOU Pisana
name: Francesco Giunta, Professor
role: STUDY_CHAIR
affiliation: Department of Intensive Care Unit, AOU Pisana
name: Imma Tatiana Borrelli, Doctor
role: PRINCIPAL_INVESTIGATOR
References: