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

Completed

• Conditions: Cardiac Surgery
• Interventions: Other: Whole blood

• Registration Number: NCT02216019
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-08
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study cohort	Whole blood	Patient undergoing planned heart surgery with cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Expression of the marker CD64, CD10 and CD16	1 hour	Evolution rate of CD64, CD10 and CD16 in the immediate postoperative cardiac surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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