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Endotoxin in Gram-negative Septic Shock

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana Identifier:
First received: May 17, 2012
Last updated: June 27, 2012
Last verified: June 2012
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock

Resource links provided by NLM:

Further study details as provided by Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • 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
whole blood

Estimated Enrollment: 20
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

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?


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to Intensive Care Unit with a diagnosis of severe sepsis or septic shock

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01602354

Department of Intensive Care Unit, AOU Pisana
Pisa, Italy, 56100
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
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
  More Information

Responsible Party: Imma Tatiana Borrelli, Principal Investigator, Azienda Ospedaliero, Universitaria Pisana Identifier: NCT01602354     History of Changes
Other Study ID Numbers: EAA G- SEP 
Study First Received: May 17, 2012
Last Updated: June 27, 2012

Keywords provided by Azienda Ospedaliero, Universitaria Pisana:
Endotoxin Activity Assay
Gram negative
Septic Shock

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation processed this record on February 20, 2017