Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

Sepsis With Acute Organ Dysfunction Clinical Trial

— SEPTIFLUX2  

Official title:

Prognostic Interest of Leucocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry During the Acute Phase of Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995448
• Other study ID #: I11020 SEPTIFLUX 2
• Status: Completed
• Phase: N/A
• First received: November 15, 2013
• Last updated: February 23, 2016
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Sepsis With Acute Organ Dysfunction
• Toxemia

Intervention

Biological:
• Blood test
Residue of blood further to NFS.

Locations

Country	Name	City	State
France	CHU Bordeaux - Service Réanimation Médicale	Bordeaux
France	CHU Henri MONDOR - Service Réanimation	Creteil
France	CHU Dijon - Service Réanimation Médicale	Dijon
France	CHU Limoges - Service de réanimation polyvalente	Limoges
France	CHU Orléans - Service de Réanimation Médicale	Orleans
France	Hôpital Cochin - service de Réanimation	Paris
France	CHU Poitiers - Service Réanimation	Poitiers
France	CHU Rennes - service de Réanimation	Rennes
France	CHU Tours - Service de Réanimation	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expression of the marker CD10	Expression of CD10 on granulocytes.	28 days	Yes
Secondary	Progession of SOFA score		48 hours	No
Secondary	Expression of the marker CD16	Expression of CD16 on granulocytes and on monocytes.	28 days	Yes
Secondary	Expression of the marker CD24	Expression of CD24 on granulocytes.	28 days	Yes
Secondary	Expression of the marker CD64	Expression of CD64 on granulocytes.	28 days	Yes
Secondary	Expression of the marker CD14	Expression of CD14 on monocytes.	28 days	Yes
Secondary	Expression of the marker CD3	Expression of CD3 on T lymphocytes.	28 days	Yes