Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

NCT ID: NCT01995448

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis With Acute Organ Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SEPSIS Blood test

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

Blood test

Intervention Type BIOLOGICAL

Residue of blood further to NFS.

Interventions

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Blood test

Residue of blood further to NFS.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno FRANCOIS, MD

Role: PRINCIPAL_INVESTIGATOR

CHU LIMOGES

Locations

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CHU Bordeaux - Service Réanimation Médicale

Bordeaux, , France

Site Status

CHU Henri MONDOR - Service Réanimation

Créteil, , France

Site Status

CHU Dijon - Service Réanimation Médicale

Dijon, , France

Site Status

CHU Limoges - Service de réanimation polyvalente

Limoges, , France

Site Status

CHU Orléans - Service de Réanimation Médicale

Orléans, , France

Site Status

Hôpital Cochin - service de Réanimation

Paris, , France

Site Status

CHU Poitiers - Service Réanimation

Poitiers, , France

Site Status

CHU Rennes - service de Réanimation

Rennes, , France

Site Status

CHU Tours - Service de Réanimation

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29705219 (View on PubMed)

Other Identifiers

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I11020 SEPTIFLUX 2

Identifier Type: -

Identifier Source: org_study_id

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