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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis With Acute Organ Dysfunction
• Intervention / Treatment: Biological: Blood test

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU Bordeaux - Service Réanimation Médicale
  • Creteil, France, 94000
    • CHU Henri MONDOR - Service Réanimation
  • Dijon, France, 21079
    • CHU Dijon - Service Réanimation Médicale
  • Limoges, France, 87042
    • CHU Limoges - Service de réanimation polyvalente
  • Orleans, France
    • CHU Orléans - Service de Réanimation Médicale
  • Paris, France, 75014
    • Hôpital Cochin - service de Réanimation
  • Poitiers, France, 86021
    • CHU Poitiers - Service Réanimation
  • Rennes, France, 35033
    • CHU Rennes - service de Réanimation
  • Tours, France, 37044
    • CHU Tours - Service de Réanimation

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

Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expression of the marker CD10	Expression of CD10 on granulocytes.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progession of SOFA score		48 hours
Expression of the marker CD16	Expression of CD16 on granulocytes and on monocytes.	28 days
Expression of the marker CD24	Expression of CD24 on granulocytes.	28 days
Expression of the marker CD64	Expression of CD64 on granulocytes.	28 days
Expression of the marker CD14	Expression of CD14 on monocytes.	28 days
Expression of the marker CD3	Expression of CD3 on T lymphocytes.	28 days

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Bruno FRANCOIS, MD, Chu Limoges

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: The acute phase of Sepsis; multiparameter 8-color flow cytometry
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: I11020 SEPTIFLUX 2