Endotoxin in Gram-negative Septic Shock

Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock

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).

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56100
    • Recruiting
    • Department of Intensive Care Unit, AOU Pisana
    • Contact: Francesco Forfori, Researcher; Email: forforiden@libero.it
    • Contact: Imma Tatiana Borrelli, Doctor; Email: tatiana_borrelli@yahoo.it
    • Principal Investigator: Imma Tatiana Borrelli, Doctor
    • Principal Investigator: Francesco Forfori, Researcher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to Intensive Care Unit with a diagnosis of severe sepsis or septic shock

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Endotoxin in blood samples	Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC	admission date (baseline)
Change of Endotoxin from baseline	Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC	3 days after admission
Change of Endotoxin from baseline	Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC	7 dayf after admission

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: May 17, 2012
• First Submitted That Met QC Criteria: May 18, 2012
• First Posted (Estimate): May 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Septic Shock; EAA; Gram negative; Endotoxin Activity Assay
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: EAA G- SEP