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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04423523
Acronym
IMMUNOPED2
Enrollment
88
Registered
2020-06-09
Start date
2020-09-02
Completion date
2025-12-02
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedure

Keywords

cardiopulmonary bypass; immunosuppression; infant, immunosuppression, infant

Brief summary

The investigators have previously reported that cardiac surgery with cardiopulmonary bypass (CPB) 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 subsequently induce an immune-suppressed state. We hypothesize that analyzing the proteomic and the whole blood transcriptomic response after cardiac surgery would provide new insights into the pathophysiological mechanisms of CPB-related inflammatory response.

Detailed description

Plasma levels of heat shock protein and inflammatory-related proteins will be measured at four time points (prior to the onset of surgery, Hour 6 postoperative, day 1 and day 3 after surgery). Whole blood transcriptomic analysis will be performed before and after surgery. The immune suppression induced by CPB will be assessed by in vitro experiments.

Interventions

DIAGNOSTIC_TESTBlood 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).

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No

Inclusion criteria

* Patient admitted to pediatric intensive care at Nantes University Hospital after cardiac surgery * Age ≤ 3 months corrected age. * Control group: patients less than 3 months old following cardiac surgery without CPB 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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma levels of inflammation-related proteins, including some DAMPs, heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9, IL-33 before and after surgery.prior to the onset of CPB, 6 hours, day 1 and day 3 after surgeryChange of plasma levels of inflammation-related proteins before and after surgery.

Secondary

MeasureTime frameDescription
Whole blood transcriptome before and after surgery.Prior to the onset of surgery and 6 hours after surgeryWhole blood transcriptomic analysis before and after surgery.
Characterization of CPB-immune dysfunction in vitroPrior to the onset of surgery and 6 hours after surgeryIn vitro experiments with immune cells phenotyping, in vitro-stimulation and intracellular cytokine staining.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAlexis Chenouard

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026