Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01995448

Acronym

SEPTIFLUX2

Enrollment

1000

Registered

2013-11-26

Start date

2013-11-30

Completion date

2015-06-30

Last updated

2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis With Acute Organ Dysfunction

Keywords

The acute phase of Sepsis, multiparameter 8-color flow cytometry

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.

Interventions

BIOLOGICALBlood test

Residue of blood further to NFS.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
Progession of SOFA score	48 hours	—
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.
Expression of the marker CD64	28 days	Expression of CD64 on granulocytes.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026