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Plasma Levels of Danger-Associated Molecular Patterns in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED2)

N

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Cardiac Surgical Procedure

Treatments

Diagnostic Test: Blood drop sampling

Study type

Observational

Funder types

Other

Identifiers

NCT04423523
RC19_0402

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Study population
Description:
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
Treatment:
Diagnostic Test: Blood drop sampling

Trial contacts and locations

1

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Central trial contact

Anne Chauvire-Drouard; Alexis Chenouard, ph

Data sourced from clinicaltrials.gov

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