Cardiac Surgical ProcedureIMMUNOPED2NCT04423523
Plasma Levels of Danger-Associated Molecular Patterns in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass
An observational study of Cardiac Surgical Procedure, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Cardiac Surgical Procedure
- What is being tested?
- Blood drop sampling
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to 2 Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)
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.
Read the 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.
- Conditions
- Cardiac Surgical Procedure
- Being tested
- Blood drop sampling
- Keywords
- cardiopulmonary bypass; immunosuppression; infant, immunosuppression, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drop samplingDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Blood drop sampling | |
| Control group | Infants under 3 months of age undergoing heavy digestive surgery and having a central venous catheter to facilitate access to blood samples. Receives: Diagnostic Test: Blood drop sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Change of plasma levels of inflammation-related proteins before and after surgery.
Measured: prior to the onset of CPB, 6 hours, day 1 and day 3 after surgery
Secondary outcomes (2)
Whole blood transcriptome before and after surgery.
Whole blood transcriptomic analysis before and after surgery.
Measured: Prior to the onset of surgery and 6 hours after surgery
Characterization of CPB-immune dysfunction in vitro
In vitro experiments with immune cells phenotyping, in vitro-stimulation and intracellular cytokine staining.
Measured: Prior to the onset of surgery and 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start2 Sep 2020
- Primary completion27 Jun 2023
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Chenouard, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423523
- Sponsor's protocol ID
- RC19_0402
- Acronym
- IMMUNOPED2
- Status last verified
- Dec 2024
- First submitted
- 14 May 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)
- ClinicalTrials.gov ID
- NCT04423523
- Acronym / sponsor ID
- IMMUNOPED2 / RC19_0402
- Conditions
- Cardiac Surgical Procedure
- Keywords
- cardiopulmonary bypass; immunosuppression; infant, immunosuppression, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Diagnostic Test: Blood drop samplingThe 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 |
| Control group | – | Diagnostic Test: Blood drop samplingInfants under 3 months of age undergoing heavy digestive surgery and having a central venous catheter to facilitate access to blood samples. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drop samplingFor 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). | Diagnostic test | Control group, Study population |
Primary outcome
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.
2 secondary outcomes
Whole blood transcriptome before and after surgery.
Time frame: Prior to the onset of surgery and 6 hours after surgery
Characterization of CPB-immune dysfunction in vitro
Time frame: Prior to the onset of surgery and 6 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Chenouard principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedure, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.