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Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis (SEPTIFLUX2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995448
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief 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. 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.

Condition or disease Intervention/treatment
Sepsis With Acute Organ Dysfunction Biological: Blood test

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Interest of Leucocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry During the Acute Phase of Sepsis
Study Start Date : November 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
SEPSIS Blood test
Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented.
Biological: Blood test
Residue of blood further to NFS.




Primary Outcome Measures :
  1. expression of the marker CD10 [ Time Frame: 28 days ]
    Expression of CD10 on granulocytes.


Secondary Outcome Measures :
  1. Progession of SOFA score [ Time Frame: 48 hours ]
  2. Expression of the marker CD16 [ Time Frame: 28 days ]
    Expression of CD16 on granulocytes and on monocytes.

  3. Expression of the marker CD24 [ Time Frame: 28 days ]
    Expression of CD24 on granulocytes.

  4. Expression of the marker CD64 [ Time Frame: 28 days ]
    Expression of CD64 on granulocytes.

  5. Expression of the marker CD14 [ Time Frame: 28 days ]
    Expression of CD14 on monocytes.

  6. Expression of the marker CD3 [ Time Frame: 28 days ]
    Expression of CD3 on T lymphocytes.


Biospecimen Retention:   Samples With DNA
Residue of blood further to NFS.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy,
  • progressive solid cancer,
  • HIV infection,
  • history of blood or inflammatory disease,
  • long-term immunosuppressive treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995448


Locations
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France
CHU Bordeaux - Service Réanimation Médicale
Bordeaux, France, 33076
CHU Henri MONDOR - Service Réanimation
Creteil, France, 94000
CHU Dijon - Service Réanimation Médicale
Dijon, France, 21079
CHU Limoges - Service de réanimation polyvalente
Limoges, France, 87042
CHU Orléans - Service de Réanimation Médicale
Orleans, France
Hôpital Cochin - service de Réanimation
Paris, France, 75014
CHU Poitiers - Service Réanimation
Poitiers, France, 86021
CHU Rennes - service de Réanimation
Rennes, France, 35033
CHU Tours - Service de Réanimation
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Bruno FRANCOIS, MD CHU LIMOGES
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01995448    
Other Study ID Numbers: I11020 SEPTIFLUX 2
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: August 2015
Keywords provided by University Hospital, Limoges:
The acute phase of Sepsis
multiparameter 8-color flow cytometry
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes