Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

Completed

• Conditions: Sepsis With Acute Organ Dysfunction
• Interventions: Biological: Blood test

• Registration Number: NCT01995448
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SEPSIS Blood test	Blood test	Patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented.

Primary Outcome Measures

Name	Time	Method
expression of the marker CD10	28 days	Expression of CD10 on granulocytes.

Secondary Outcome Measures

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

Trial Locations

Locations (9)

CHU Limoges - Service de réanimation polyvalente; 🇫🇷 Limoges, France

CHU Orléans - Service de Réanimation Médicale; 🇫🇷 Orleans, France

Hôpital Cochin - service de Réanimation; 🇫🇷 Paris, France

CHU Henri MONDOR - Service Réanimation; 🇫🇷 Creteil, France

CHU Bordeaux - Service Réanimation Médicale; 🇫🇷 Bordeaux, France

CHU Rennes - service de Réanimation; 🇫🇷 Rennes, France

CHU Poitiers - Service Réanimation; 🇫🇷 Poitiers, France

CHU Dijon - Service Réanimation Médicale; 🇫🇷 Dijon, France

CHU Tours - Service de Réanimation; 🇫🇷 Tours, France