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OpenTrials
Completed

NCT Number: NCT01995448

Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux - Service Réanimation Médicale, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood test

Biological

Residue of blood further to NFS.

Primary outcomes

  1. expression of the marker CD10

    Time frame: 28 days

    Expression of CD10 on granulocytes.

Secondary outcomes

  1. Progession of SOFA score

    Time frame: 48 hours

  2. Expression of the marker CD16

    Time frame: 28 days

    Expression of CD16 on granulocytes and on monocytes.

  3. Expression of the marker CD24

    Time frame: 28 days

    Expression of CD24 on granulocytes.

  4. Expression of the marker CD64

    Time frame: 28 days

    Expression of CD64 on granulocytes.

  5. Expression of the marker CD14

    Time frame: 28 days

    Expression of CD14 on monocytes.

  6. Expression of the marker CD3

    Time frame: 28 days

    Expression of CD3 on T lymphocytes.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: SEPTIFLUX2

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2013
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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