SepsisSEPSIROSNCT03846596
Flow Cytometry Analysis of the Reactive Oxygen Species in Immature Granulocytes in Septic Patient
An observational study of Sepsis, run by University Hospital, Limoges at 1 site in France.
Trial summary
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Early during sepsis course, immature neutrophils could be found in the bloodstream and may be less efficient than mature neutrophils in reactive oxygen species (ROS) production. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Additional blood tube
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2019to 10 Mar 2020
- 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: Patient hospitalized in intensive car or emergency department for acute sepsis
Who may be able to join
- Adult patients hospitalized in ICU or ED for acute sepsis
Who cannot join
- Immunosupressed patients
- Active cancer
- HIV
- Hematological or inflammatory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Early during sepsis course, immature neutrophils could be found in the bloodstream and may be less efficient than mature neutrophils in reactive oxygen species (ROS) production. ROS induce an oxidative stress for bacteria which can protect through the SOS response. The main objective is to evaluate the level of ROS produced in the early steps of sepsis by the immature neutrophils.
Read the detailed description
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. The immune system is activated by both pathogen-associated and host-derived molecular patterns. A strong response of neutrophils is engaged and both innate and adaptive immune system homeostasis are strongly affected. Neutrophils are able to produce high concentrations of inducible reactive oxygen species (ROS), leading to an oxidative stress. ROS can be released extracellularly at the site of infection or intracellularly in the phagolysosome. At early phase of sepsis, immature granulocytes are present in the bloodstream and could help to predict sepsis deterioration. However, it has also been shown that they are less efficient than mature granulocytes in ROS production and phagocytosis. ROS are potent stressors for bacteria and can directly or indirectly damage DNA. Bacteria can protect against DNA damage through the SOS response, which is a coordinated cellular response regulated by a repressor, LexA, and a sensor/activator, RecA. The bacterial SOS response is involved in acquisition of resistances to antibiotics through increasing frequencies of spontaneous mutations or increasing the expression of resistance and adaptation genes. The hypothesis that the low-level production of ROS by immature granulocytes in the early steps of sepsis could be beneficial for both the host, as a high level of ROS induce organ damage and dysfunction, and the pathogen, as low concentrations of ROS would be able to induce the SOS response allowing bacteria to enhance an adaptive response. The main objective it is to evaluate the level of ROS produced by the immature granulocytes in septic patient. Then, it will be assess if it could promote antibiotic resistance expression via SOS-induced integron gene cassette rearrangements.
- Conditions
- Sepsis
- Being tested
- Additional blood tube
- Keywords
- Sepsis, reactive oxygen species, immature neutrophils
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood tubeBiological
Additional blood tube during care
| Study group | Role | What they receive |
|---|---|---|
| Evaluated | An additional blood tube will be taken from patients hospitalized in intensive care or emergency department for acute sepsis Receives: Biological: Additional blood tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROS level by Flow cytometry in immature granulocytes dosage sepsis
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the immature granulocytes from the onset of sepsis to the acute phase
Measured: Day 1
Secondary outcomes (6)
ROS level by Flow cytometry in mature granulocytes dosage sepsis
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the mature granulocytes from the onset of sepsis to the acute phase
Measured: Day 1
Bacterial phagocytosis capacity of granulocytes assess by flow cytometry
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the number of ingested bacteria.
Measured: Day 1
SOS response activation by bacteria determined by flow cytometry
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the expression of the SOS gene by the bacteria.
Measured: Day 1
Hospital mortality
number of death
Measured: Day 28
ROS level by Flow cytometry in monocyte dosage sepsis
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the monocyte from the onset of sepsis to the acute phase
Measured: Day 1
ROS level by Flow cytometry in lymphocyte dosage sepsis
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the lymphocyte from the onset of sepsis to the acute phase
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start26 Mar 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Why it stopped: Not enough patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas DAIX, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846596
- Sponsor's protocol ID
- 87RI18-0031 (SEPSIROS)
- Acronym
- SEPSIROS
- Status last verified
- Apr 2020
- First submitted
- 15 Feb 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Cytometry Analysis of the Reactive Oxygen Species in Immature Granulocytes in Septic Patient
- ClinicalTrials.gov ID
- NCT03846596
- Acronym / sponsor ID
- SEPSIROS / 87RI18-0031 (SEPSIROS)
- Conditions
- Sepsis
- Keywords
- Sepsis, reactive oxygen species, immature neutrophils
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough patient
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 19 Feb 2019 (actual)
- 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.
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Early during sepsis course, immature neutrophils could be found in the bloodstream and may be less efficient than mature neutrophils in reactive oxygen species (ROS) production. ROS induce an oxidative stress for bacteria which can protect through the SOS response. The main objective is to evaluate the level of ROS produced in the early steps of sepsis by the immature neutrophils.
Detailed description
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. The immune system is activated by both pathogen-associated and host-derived molecular patterns. A strong response of neutrophils is engaged and both innate and adaptive immune system homeostasis are strongly affected. Neutrophils are able to produce high concentrations of inducible reactive oxygen species (ROS), leading to an oxidative stress. ROS can be released extracellularly at the site of infection or intracellularly in the phagolysosome. At early phase of sepsis, immature granulocytes are present in the bloodstream and could help to predict sepsis deterioration. However, it has also been shown that they are less efficient than mature granulocytes in ROS production and phagocytosis. ROS are potent stressors for bacteria and can directly or indirectly damage DNA. Bacteria can protect against DNA damage through the SOS response, which is a coordinated cellular response regulated by a repressor, LexA, and a sensor/activator, RecA. The bacterial SOS response is involved in acquisition of resistances to antibiotics through increasing frequencies of spontaneous mutations or increasing the expression of resistance and adaptation genes. The hypothesis that the low-level production of ROS by immature granulocytes in the early steps of sepsis could be beneficial for both the host, as a high level of ROS induce organ damage and dysfunction, and the pathogen, as low concentrations of ROS would be able to induce the SOS response allowing bacteria to enhance an adaptive response. The main objective it is to evaluate the level of ROS produced by the immature granulocytes in septic patient. Then, it will be assess if it could promote antibiotic resistance expression via SOS-induced integron gene cassette rearrangements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluated | – | Biological: Additional blood tubeAn additional blood tube will be taken from patients hospitalized in intensive care or emergency department for acute sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in intensive car or emergency department for acute sepsis
Key inclusion criteria (1 listed)
- Adult patients hospitalized in ICU or ED for acute sepsis
Key exclusion criteria (4 listed)
- Immunosupressed patients
- Active cancer
- HIV
- Hematological or inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional blood tubeAdditional blood tube during care | Biological | Evaluated |
Primary outcome
ROS level by Flow cytometry in immature granulocytes dosage sepsis
Time frame: Day 1
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the immature granulocytes from the onset of sepsis to the acute phase
6 secondary outcomes
ROS level by Flow cytometry in mature granulocytes dosage sepsis
Time frame: Day 1
Bacterial phagocytosis capacity of granulocytes assess by flow cytometry
Time frame: Day 1
SOS response activation by bacteria determined by flow cytometry
Time frame: Day 1
Hospital mortality
Time frame: Day 28
ROS level by Flow cytometry in monocyte dosage sepsis
Time frame: Day 1
ROS level by Flow cytometry in lymphocyte dosage sepsis
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Thomas DAIX, MD principal investigator
University Hospital, Limoges
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 Sepsis, run by University Hospital, Limoges at 1 site in France.
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 1 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: stopped early, as of the sponsor's last update on 8 Apr 2020. 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 France. 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?
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROS level by Flow cytometry in immature granulocytes dosage sepsis (time frame: Day 1). 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 8 Apr 2020.