NCT01995448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

November 15, 2013

Last Update Submit

February 23, 2016

Conditions

Sepsis With Acute Organ Dysfunction

Keywords

The acute phase of Sepsismultiparameter 8-color flow cytometry

Outcome Measures

Primary Outcomes (1)

  • expression of the marker CD10

    Expression of CD10 on granulocytes.

    28 days

Secondary Outcomes (6)

  • Progession of SOFA score

    48 hours

  • Expression of the marker CD16

    28 days

  • Expression of the marker CD24

    28 days

  • Expression of the marker CD64

    28 days

  • Expression of the marker CD14

    28 days

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Blood testBIOLOGICAL

Residue of blood further to NFS.

SEPSIS Blood test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy,
  • progressive solid cancer,
  • HIV infection,
  • history of blood or inflammatory disease,
  • long-term immunosuppressive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU Bordeaux - Service Réanimation Médicale

Bordeaux, 33076, France

Location

CHU Henri MONDOR - Service Réanimation

Créteil, 94000, France

Location

CHU Dijon - Service Réanimation Médicale

Dijon, 21079, France

Location

CHU Limoges - Service de réanimation polyvalente

Limoges, 87042, France

Location

CHU Orléans - Service de Réanimation Médicale

Orléans, France

Location

Hôpital Cochin - service de Réanimation

Paris, 75014, France

Location

CHU Poitiers - Service Réanimation

Poitiers, 86021, France

Location

CHU Rennes - service de Réanimation

Rennes, 35033, France

Location

CHU Tours - Service de Réanimation

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 29705219DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Residue of blood further to NFS.

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Bruno FRANCOIS, MD

    CHU LIMOGES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 26, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 24, 2016

Record last verified: 2015-08

Locations

FR(9)