Endotoxin in Gram-negative Septic Shock

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease
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?

Study Design

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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

Groups and Cohorts

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Group/Cohort
Gram-negative Septic shock; Patients affected by Gram-negative septic shock

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Level of Endotoxin in blood samples [ Time Frame: admission date (baseline) ]
   Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
2. Change of Endotoxin from baseline [ Time Frame: 3 days after admission ]
   Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
3. 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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Azienda Ospedaliero, Universitaria Pisana

Investigators

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	June 28, 2012
Last Verified:	June 2012

Keywords provided by Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana:

Endotoxin Activity Assay; Gram negative; Septic Shock; EAA

Additional relevant MeSH terms:

Shock; Shock, Septic; Pathologic Processes; Sepsis	Infection; Systemic Inflammatory Response Syndrome; Inflammation