Plasma Levels of Danger-Associated Molecular Patterns in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass

Cardiac Surgical Procedure Clinical Trial

— IMMUNOPED2  

Official title:

Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423523
• Other study ID #: RC19_0402
• Status: Recruiting
• Start date: September 2, 2020
• Est. completion date: April 2, 2025

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Alexis Chenouard, ph
• Phone: 02.44.76.82.21
• Email: alexis.chenouard[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators have previously reported that cardiac surgery with CPB ( cardiopulmonary bypass) in young infants induced a drastic reduction in mHLA-DR ( Human Leucocyte Antigen) expression, which represents one of innate immune mediator. Danger-Associated Molecular Patterns (DAMPs) can elicit immune response and may subsequentely induce an immune-suppressed state. The investigators hypothesize that CPB causes excessive DAMP release, leading to the development of immune suppression. Thus, DAMPs release will be assessed in patients undergoing CBP, and consequences on immune suppression will be evaluated.

Description:

Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 will be measured at four time points (prior to the onset of CPB, Hour 6 postoperative, day 1 and day 3 after surgery). HLA-DR gene expression will be determined before surgery and at day 3 postoperative. The direct effect of DAMPs release and immune suppression will be assessed by in vitro experiments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2, 2025
• Est. primary completion date: September 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Patients = 3 months undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Lack of parental consent

Related Conditions & MeSH terms

• Cardiac Surgical Procedure

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP.	Change of plasma levels of DAMPs after cardiopulmonary bypass Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP.	prior to the onset of CPB, 6 hours, day 1 and day 3 after surgery
Secondary	Effect of DAMPs on immune function:In vitro change of HLA-DR expression.	In vitro change of HLA-DR expression induced by plasma containing different concentrations of DAMPs.	6 hours after surgery
Secondary	Effect of DAMPs on immune function:Secretion of IL-10 ( Interleukine 10).	Secretion of IL-10 by different immune cells induced by plasma containing different concentrations of DAMPs.	6 hours after surgery