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Endotoxin in Gram-negative Septic Shock

This study is currently recruiting participants.
Verified June 2012 by Azienda Ospedaliero, Universitaria Pisana
Sponsor:
Information provided by (Responsible Party):
Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier:
NCT01602354
First received: May 17, 2012
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  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 Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 17, 2012
Last Updated: June 27, 2012
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013