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 Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01602354

First Posted: May 21, 2012

Last Update Posted: June 28, 2012

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Information provided by (Responsible Party):

Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana

Purpose

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
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:

MedlinePlus related topics: Shock

U.S. FDA Resources

Further study details as provided by Imma Tatiana Borrelli, 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)

Groups/Cohorts
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?

Eligibility

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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

Information from the National Library of Medicine

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

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


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 Submitted:	May 17, 2012
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

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