Gram Negative Septic ShockNCT01602354
Endotoxin in Gram-negative Septic Shock
An observational study of Gram Negative Septic Shock, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram Negative Septic Shock
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Intensive Care Unit with a diagnosis of severe sepsis or septic shock
Who may be able to join
- diagnosis of severe sepsis or septic shock
- acquisition of informed consent
- age over 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Intensive Care Unit, AOU Pisana
Pisa, 56100
Francesco Forfori, Researcher, forforiden@libero.it
Imma Tatiana Borrelli, Doctor, tatiana_borrelli@yahoo.it
About this study
Official title: 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).
Read the 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?
- Conditions
- Gram Negative Septic Shock
- Keywords
- Endotoxin Activity Assay, Gram negative, Septic Shock, EAA
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gram-negative Septic shock | Patients affected by Gram-negative septic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Endotoxin in blood samples
Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
Measured: admission date (baseline)
Change of Endotoxin from baseline
Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
Measured: 3 days after admission
Change of Endotoxin from baseline
Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC
Measured: 7 dayf after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram Negative Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imma Tatiana Borrelli, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Francesco Forfori, Researcher, Study director, Department of Intensive Care Unit, Azienda Ospedaliero-Universitaria (AOU) PisanaFrancesco Giunta, Professor, Study chair, Depatment of Intensive Care Unit, AOU PisanaImma Tatiana Borrelli, Doctor, Principal investigator, Department of Intensive Care Unit, AOU Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602354
- Sponsor's protocol ID
- EAA G- SEP
- Status last verified
- Jun 2012
- First submitted
- 17 May 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock
- ClinicalTrials.gov ID
- NCT01602354
- Acronym / sponsor ID
- EAA G- SEP
- Conditions
- Gram Negative Septic Shock
- Keywords
- Endotoxin Activity Assay, Gram negative, Septic Shock, EAA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gram-negative Septic shock | – | –Patients affected by Gram-negative septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Intensive Care Unit with a diagnosis of severe sepsis or septic shock
Key inclusion criteria (3 listed)
- diagnosis of severe sepsis or septic shock
- acquisition of informed consent
- age over 18 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Forfori, Researcher study director
Department of Intensive Care Unit, Azienda Ospedaliero-Universitaria (AOU) Pisana
Francesco Giunta, Professor study chair
Depatment of Intensive Care Unit, AOU Pisana
Imma Tatiana Borrelli, Doctor principal investigator
Department of Intensive Care Unit, AOU Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gram Negative Septic Shock, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Endotoxin in blood samples (time frame: admission date (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.