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

Recruiting

• Conditions: Cardiac Surgical Procedure

• Registration Number: NCT04423523
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-06-07
• Study First Posted: 2020-06-09
• Study Start: 2020-09-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-06-02
• Study Completion: 2025-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient admitted to pediatric intensive care at Nantes University Hospital after cardiac surgery with bypass graft
• Age ≤ 3 months corrected age. Control group: patients less than 3 months old following cardiac surgery without CEC or digestive surgery with a central venous catheter.

Exclusion Criteria

• Futility of care with cessation of blood tests as part of a limitation of active therapies;
• Absence of parents for information
• Refusal of parents after information (Lack of parental consent)
• Blood volume collected for medical purposes incompatible with the needs of the research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Effect of DAMPs on immune function:In vitro change of HLA-DR expression.	6 hours after surgery	In vitro change of HLA-DR expression induced by plasma containing different concentrations of DAMPs.
Effect of DAMPs on immune function:Secretion of IL-10 ( Interleukine 10).	6 hours after surgery	Secretion of IL-10 by different immune cells induced by plasma containing different concentrations of DAMPs.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France