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

NCT04423523 | Completed

• 1 other identifier: RC19_0402
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgical Procedure

Keywords

cardiopulmonary bypass; immunosuppression; infant; immunosuppression; infant

Outcome Measures

Primary Outcomes (1)

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

  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.

  prior to the onset of CPB, 6 hours, day 1 and day 3 after surgery

Secondary Outcomes (2)

• 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 Arms (1)

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

Diagnostic Test: Blood drop sampling

Interventions

Blood drop sampling 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).

Study population

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to pediatric resuscitation at the Nantes University Hospital after cardiac surgery under CEC ( extra-corporal circulation) and aged less than 3 months meeting the criteria for inclusion and non-inclusion of the study will be included. We can objectify the recruitment of 80 patients in total over 3 years. Since natural evolution (variation of rates and their kinetics) of the secretion of different DAMPs during the first months of life is unknown, the investigators added a control group to know the expression and kinetics of DAMPs outside cardiac surgery under CEC. This control group will be defined by infants under 3 months of age undergoing heavy digestive surgery and having a central venous catheter to facilitate access to blood samples (n = 20).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Study Officials

• Alexis Chenouard

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 9, 2020
• Study Start: September 2, 2020
• Primary Completion: June 27, 2023
• Study Completion: December 2, 2025
• Last Updated: December 17, 2025

Record last verified: 2024-12

Locations

FR (1)