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

NCT ID: NCT04423523

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-02

Study Completion Date

2025-12-02

Brief Summary

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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

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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

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Cardiac Surgical Procedure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

The study population must correspond to the research inclusion criteria: Patient admitted to pediatric intensive care at Nantes University Hospital after cardiac surgery on bypass grafts

Blood drop sampling

Intervention Type DIAGNOSTIC_TEST

For 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).

Interventions

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Blood drop sampling

For 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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Chenouard

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC19_0402

Identifier Type: -

Identifier Source: org_study_id