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Completed

NCT Number: NCT02216019

Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery

In septic patients, Septiflux1 study identified immature granulocytes which may have a diagnostic and prognostic interest. However, with these preliminary results it is not possible to make a difference between what is linked to the infection and what is a consequence of the inflammation which goes along with the septic process. Using flow cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary bypass in heart surgery could make possible to test the diagnostic interest of the immature granulocytes but also to attribute a prognostic value for the occurrence of post-operative infections.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Limoges - Service de réanimation polyvalente

Limoges, 87042, France

About this study

Expression of CD10, CD16, CD24, CD64 on granulocytes, of CD14 and CD16 on monocytes and of CD3 on T lymphocytes.

Flow cytometers will all be calibrated the same way using common reagents (known fluorescent calibration beads). Moreover, CD45 and CD3 level of expression on lymphocytes will help to check that the collection of data is standardized between the different centers.

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 undergoing planned heart surgery with cardiopulmonary bypass

Exclusion criteria

  • Pregnancy,
  • progressive solid cancer,
  • HIV infection,
  • history of blood or inflammatory disease,
  • long-term immunosuppressive treatment,
  • urgent surgical intervention,
  • documented preoperative infection

Treatment and study plan

Whole blood

Other

preoparatoire whole blood and postoperative whole blood

Primary outcomes

  1. Expression of the marker CD64, CD10 and CD16

    Time frame: 1 hour

    Evolution rate of CD64, CD10 and CD16 in the immediate postoperative cardiac surgery

Secondary outcomes

  1. Early onset of infectious complications

    Time frame: 7 days

    Early onset of infectious complications in the 7 days post-operative

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: INFLUX

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2014
Registry last updated
Aug 15, 2014

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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