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

Cardiac Surgery Clinical Trial

— IMMUNOPED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309839
• Other study ID #: RC17_0359
• Status: Completed
• Start date: January 29, 2018
• Est. completion date: April 13, 2019

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 13, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Patients aged = 28 days

• Admission after cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

• Lack of parental consent

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• Blood collection
A sample of an additional blood tube will be taken in parallel with the blood test carried out for the treatment.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Fédération Française de Cardiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HLA-DR expression	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)	Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass
Secondary	Cytokines measurements	Pro and anti-inflammatory cytokine concentrations in the plasma measured by multiplex immunoassay	Preoperatively, and 1, 2, 3 and 4 days after the end of cardiopulmonary bypass