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Clinical Trials/NCT04423523
NCT04423523
Completed
N/A

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

Nantes University Hospital1 site in 1 country88 target enrollmentSeptember 2, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Surgical Procedure
Sponsor
Nantes University Hospital
Enrollment
88
Locations
1
Primary Endpoint
Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP.
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2020
End Date
December 2, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP.

Time Frame: 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 Outcomes

  • Effect of DAMPs on immune function:In vitro change of HLA-DR expression.(6 hours after surgery)
  • Effect of DAMPs on immune function:Secretion of IL-10 ( Interleukine 10).(6 hours after surgery)

Study Sites (1)

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