NCT02216019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

August 11, 2014

Last Update Submit

August 13, 2014

Conditions

Cardiac Surgery

Keywords

cardiac surgeryinfectious complication

Outcome Measures

Primary Outcomes (1)

  • Expression of the marker CD64, CD10 and CD16

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

    1 hour

Secondary Outcomes (1)

  • Early onset of infectious complications

    7 days

Study Arms (1)

study cohort

Patient undergoing planned heart surgery with cardiopulmonary bypass

Other: Whole blood

Interventions

Whole bloodOTHER

preoparatoire whole blood and postoperative whole blood

study cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient undergoing planned heart surgery with cardiopulmonary bypass

You may qualify if:

  • Patient older than 18 years old
  • Patient undergoing planned heart surgery with cardiopulmonary bypass

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Limoges - Service de réanimation polyvalente

Limoges, Limoges, 87042, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

  • Bruno FRANCOIS, MD

    CHU LIMOGES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 13, 2014

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

FR(1)