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

NCT ID: NCT02216019

Last Updated: 2014-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study cohort

Patient undergoing planned heart surgery with cardiopulmonary bypass

Whole blood

Intervention Type OTHER

preoparatoire whole blood and postoperative whole blood

Interventions

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Whole blood

preoparatoire whole blood and postoperative whole blood

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno FRANCOIS, MD

Role: PRINCIPAL_INVESTIGATOR

CHU LIMOGES

Locations

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CHU de Limoges - Service de réanimation polyvalente

Limoges, Limoges, France

Site Status

Countries

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France

Other Identifiers

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I13015 Influx

Identifier Type: -

Identifier Source: org_study_id

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