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

August 13, 2014 updated by: University Hospital, Limoges
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • CHU de Limoges - Service de réanimation polyvalente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient undergoing planned heart surgery with cardiopulmonary bypass

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study cohort
Patient undergoing planned heart surgery with cardiopulmonary bypass
Other: Whole blood
preoparatoire whole blood and postoperative whole blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early onset of infectious complications
Time Frame: 7 days
Early onset of infectious complications in the 7 days post-operative
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Bruno FRANCOIS, MD, CHU Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I13015 Influx

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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