HLA-DR Expression in Neonates After Cardiac Surgery Under Cardiopulmonary Bypass

Completed

• Conditions: Cardiac Surgery

• Registration Number: NCT03309839
• Lead Sponsor: Nantes University Hospital

Brief Summary

The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in neonates who underwent cardiac surgery with cardiopulmonary bypasss.

We hypothesize that HLA-DR expression in neonates is predictive of septic complications after cardiopulmonary bypass

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-16
• Study Start: 2018-01-29
• Primary Completion: 2019-03-14
• Study Completion: 2019-04-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients aged ≤ 28 days
• Admission after cardiac surgery under cardiopulmonary bypass

Exclusion Criteria

• Lack of parental consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HLA-DR expression	Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass	Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences) Number of HLA-DR molecules per monocyte (AB/c) determined by flow cytometry on whole blood using a Quantibrite phycoerythrin fluorescence quantitation kit (BD Biosciences)

Secondary Outcome Measures

Name	Time	Method
Cytokines measurements	Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass	Pro and anti-inflammatory cytokine concentrations in the plasma measured by multiplex immunoassay

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France