SEPTIFLUX2: Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

Sponsor

University Hospital, Limoges (Other)

Overall Status

Completed

CT.gov ID

NCT01995448

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

111.1

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Sepsis With Acute Organ Dysfunction	Biological: Blood test

Study Design

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 :

Nov 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

expression of the marker CD10 [28 days]
Expression of CD10 on granulocytes.

Secondary Outcome Measures

Progession of SOFA score [48 hours]
Expression of the marker CD16 [28 days]
Expression of CD16 on granulocytes and on monocytes.
Expression of the marker CD24 [28 days]
Expression of CD24 on granulocytes.
Expression of the marker CD64 [28 days]
Expression of CD64 on granulocytes.
Expression of the marker CD14 [28 days]
Expression of CD14 on monocytes.
Expression of the marker CD3 [28 days]
Expression of CD3 on T lymphocytes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Bordeaux - Service Réanimation Médicale	Bordeaux	France	33076
2	CHU Henri MONDOR - Service Réanimation	Creteil	France	94000
3	CHU Dijon - Service Réanimation Médicale	Dijon	France	21079
4	CHU Limoges - Service de réanimation polyvalente	Limoges	France	87042
5	CHU Orléans - Service de Réanimation Médicale	Orleans	France
6	Hôpital Cochin - service de Réanimation	Paris	France	75014
7	CHU Poitiers - Service Réanimation	Poitiers	France	86021
8	CHU Rennes - service de Réanimation	Rennes	France	35033
9	CHU Tours - Service de Réanimation	Tours	France	37044

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator: Bruno FRANCOIS, MD, CHU LIMOGES

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Limoges

ClinicalTrials.gov Identifier:

NCT01995448

Other Study ID Numbers:

I11020 SEPTIFLUX 2

First Posted:

Nov 26, 2013

Last Update Posted:

Feb 24, 2016

Last Verified:

Aug 1, 2015

Keywords provided by University Hospital, Limoges

The acute phase of Sepsis

multiparameter 8-color flow cytometry

Additional relevant MeSH terms:

Sepsis

Toxemia

Study Results

No Results Posted as of Feb 24, 2016