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

Cardiac Surgery Clinical Trial

— INFLUX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216019
• Other study ID #: I13015 Influx
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: August 13, 2014
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2014
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• Whole blood
preoparatoire whole blood and postoperative whole blood

Locations

Country	Name	City	State
France	CHU de Limoges - Service de réanimation polyvalente	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of the marker CD64, CD10 and CD16	Evolution rate of CD64, CD10 and CD16 in the immediate postoperative cardiac surgery	1 hour	No
Secondary	Early onset of infectious complications	Early onset of infectious complications in the 7 days post-operative	7 days	No