Clinical trial NCT01995448: Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis
Official title: Prognostic Interest of Leucocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry During the Acute Phase of Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis With Acute Organ Dysfunction
Keywords: The acute phase of Sepsis
multiparameter 8-color flow cytometry
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: expression of the marker CD10
timeFrame: 28 days
Secondary outcomes:
measure: Progession of SOFA score
timeFrame: 48 hours
measure: Expression of the marker CD16
timeFrame: 28 days
measure: Expression of the marker CD24
timeFrame: 28 days
measure: Expression of the marker CD64
timeFrame: 28 days
measure: Expression of the marker CD14
timeFrame: 28 days
measure: Expression of the marker CD3
timeFrame: 28 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - Service Réanimation Médicale
city: Creteil
country: France
facility: CHU Henri MONDOR - Service Réanimation
city: Dijon
country: France
facility: CHU Dijon - Service Réanimation Médicale
city: Limoges
country: France
facility: CHU Limoges - Service de réanimation polyvalente
city: Orleans
country: France
facility: CHU Orléans - Service de Réanimation Médicale
city: Paris
country: France
facility: Hôpital Cochin - service de Réanimation
city: Poitiers
country: France
facility: CHU Poitiers - Service Réanimation
city: Rennes
country: France
facility: CHU Rennes - service de Réanimation
city: Tours
country: France
facility: CHU Tours - Service de Réanimation
Study officials:
affiliation: CHU LIMOGES
name: Bruno FRANCOIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.