Sepsis With Acute Organ DysfunctionSEPTIFLUX2NCT01995448
Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis
An observational study of Sepsis With Acute Organ Dysfunction, run by University Hospital, Limoges at 9 sites in France.
Trial summary
Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if they are considered separately. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis With Acute Organ Dysfunction
- What is being tested?
- Blood test
- How many people
- 1,000 participants
- Where
- 9 sitesFrance
- Study dates
- Nov 2013to Jun 2015
- 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 with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented
Who may be able to join
- patient older than 18 years old
- Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented
Who cannot join
- Pregnancy,
- progressive solid cancer,
- HIV infection,
- history of blood or inflammatory disease,
- long-term immunosuppressive treatment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU Bordeaux - Service Réanimation Médicale
Bordeaux, 33076
CHU Henri MONDOR - Service Réanimation
Créteil, 94000
CHU Dijon - Service Réanimation Médicale
Dijon, 21079
CHU Limoges - Service de réanimation polyvalente
Limoges, 87042
CHU Orléans - Service de Réanimation Médicale
Orléans
Hôpital Cochin - service de Réanimation
Paris, 75014
CHU Poitiers - Service Réanimation
Poitiers, 86021
CHU Rennes - service de Réanimation
Rennes, 35033
CHU Tours - Service de Réanimation
Tours, 37044
About this study
Official title: Prognostic Interest of Leucocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry During the Acute Phase of Sepsis
Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if they are considered separately. The extensive experimental data which have been published contrast with the hematological data collected by the physician at patient's bedside especially regarding neutrophils and platelets levels. When there is no obvious clinical sign, a biological tool reflecting the patient's immune status could be useful to understand the physiopathology of Sepsis and to predict the progression of the disease in the patient. On the long-term it could also help to define management strategies.
- Conditions
- Sepsis With Acute Organ Dysfunction
- Being tested
- Blood test
- Keywords
- The acute phase of Sepsis, multiparameter 8-color flow cytometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
Residue of blood further to NFS.
| Study group | Role | What they receive |
|---|---|---|
| SEPSIS Blood test | Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented. Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of the marker CD10
Expression of CD10 on granulocytes.
Measured: 28 days
Secondary outcomes (6)
Progession of SOFA score
Measured: 48 hours
Expression of the marker CD16
Expression of CD16 on granulocytes and on monocytes.
Measured: 28 days
Expression of the marker CD24
Expression of CD24 on granulocytes.
Measured: 28 days
Expression of the marker CD64
Expression of CD64 on granulocytes.
Measured: 28 days
Expression of the marker CD14
Expression of CD14 on monocytes.
Measured: 28 days
Expression of the marker CD3
Expression of CD3 on T lymphocytes.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis With Acute Organ DysfunctionStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno FRANCOIS, MD, Principal investigator, CHU LIMOGES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995448
- Sponsor's protocol ID
- I11020 SEPTIFLUX 2
- Acronym
- SEPTIFLUX2
- Status last verified
- Aug 2015
- First submitted
- 15 Nov 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Daix T, Guerin E, Tavernier E, Mercier E, Gissot V, Herault O, Mira JP, Dumas F, Chapuis N, Guitton C, Bene MC, Quenot JP, Tissier C, Guy J, Piton G, Roggy A, Muller G, Legac E, de Prost N, Khellaf M, Wagner-Ballon O, Coudroy R, Dindinaud E, Uhel F, Roussel M, Lafon T, Jeannet R, Vargas F, Fleureau C, Roux M, Allou K, Vignon P, Feuillard J, Francois B; Septiflux Trial Group. Multicentric Standardized Flow Cytometry Routine Assessment of Patients With Sepsis to Predict Clinical Worsening. Chest. 2018 Sep;154(3):617-627. doi: 10.1016/j.chest.2018.03.058. Epub 2018 Apr 26.
PubMed 29705219
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Interest of Leucocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry During the Acute Phase of Sepsis
- ClinicalTrials.gov ID
- NCT01995448
- Acronym / sponsor ID
- SEPTIFLUX2 / I11020 SEPTIFLUX 2
- Conditions
- Sepsis With Acute Organ Dysfunction
- Keywords
- The acute phase of Sepsis, multiparameter 8-color flow cytometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Nov 2013 (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.
Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if they are considered separately. The extensive experimental data which have been published contrast with the hematological data collected by the physician at patient's bedside especially regarding neutrophils and platelets levels. When there is no obvious clinical sign, a biological tool reflecting the patient's immune status could be useful to understand the physiopathology of Sepsis and to predict the progression of the disease in the patient. On the long-term it could also help to define management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEPSIS Blood test | – | Biological: Blood testPatient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented
Key inclusion criteria (2 listed)
- patient older than 18 years old
- Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented
Key exclusion criteria (5 listed)
- Pregnancy,
- progressive solid cancer,
- HIV infection,
- history of blood or inflammatory disease,
- long-term immunosuppressive treatment
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 |
|---|---|---|
| Blood testResidue of blood further to NFS. | Biological | SEPSIS Blood test |
Primary outcome
expression of the marker CD10
Time frame: 28 days
Expression of CD10 on granulocytes.
6 secondary outcomes
Progession of SOFA score
Time frame: 48 hours
Expression of the marker CD16
Time frame: 28 days
Expression of the marker CD24
Time frame: 28 days
Expression of the marker CD64
Time frame: 28 days
Expression of the marker CD14
Time frame: 28 days
Expression of the marker CD3
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Derived from this study: PubMed 29705219Daix T, Guerin E, Tavernier E, Mercier E, Gissot V, Herault O, Mira JP, Dumas F, Chapuis N, Guitton C, Bene MC, Quenot JP, Tissier C, Guy J, Piton G, Roggy A, Muller G, Legac E, de Prost N, Khellaf M, Wagner-Ballon O, Coudroy R, Dindinaud E, Uhel F, Roussel M, Lafon T, Jeannet R, Vargas F, Fleureau C, Roux M, Allou K, Vignon P, Feuillard J, Francois B; Septiflux Trial Group. Multicentric Standardized Flow Cytometry Routine Assessment of Patients With Sepsis to Predict Clinical Worsening. Chest. 2018 Sep;154(3):617-627. doi: 10.1016/j.chest.2018.03.058. Epub 2018 Apr 26.
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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.
Bruno FRANCOIS, MD principal investigator
CHU LIMOGES
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis With Acute Organ Dysfunction, run by University Hospital, Limoges at 9 sites 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
expression of the marker CD10 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995448, which also lists 1 linked publication.
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 24 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.