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Trials / Completed

CompletedNCT04423523

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
88 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
3 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBlood drop samplingFor each patient included, 1 additional EDTA blood tube (2 ml) will be collected for research purposes at different times (4 visits), and 1 PAXgene-type tube adapted for pediatric collection of only 500 μl (2 visits).

Timeline

Start date
2020-09-02
Primary completion
2023-06-27
Completion
2025-12-02
First posted
2020-06-09
Last updated
2025-12-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04423523. Inclusion in this directory is not an endorsement.