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Completed

NCT Number: NCT04423523

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

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.

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Key information

Conditions

Cardiac Surgical Procedure

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

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

    Change of plasma levels of inflammation-related proteins before and after surgery.

Secondary outcomes

  1. Whole blood transcriptome before and after surgery.

    Time frame: Prior to the onset of surgery and 6 hours after surgery

    Whole blood transcriptomic analysis before and after surgery.

  2. Characterization of CPB-immune dysfunction in vitro

    Time frame: Prior to the onset of surgery and 6 hours after surgery

    In vitro experiments with immune cells phenotyping, in vitro-stimulation and intracellular cytokine staining.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: IMMUNOPED2

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Jun 9, 2020
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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