Measuring immune response in infants after heart surgery
Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)
This study looks at how heart surgery affects the immune system in young infants by checking certain proteins in their blood before and after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 3 Months |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT04423523 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the release of Danger-Associated Molecular Patterns (DAMPs) in young infants undergoing cardiac surgery with cardiopulmonary bypass (CPB). Researchers will measure plasma levels of specific proteins at various time points before and after surgery to assess the impact of CPB on immune suppression. The study aims to understand how excessive DAMP release may contribute to an immune-suppressed state in these patients. In vitro experiments will also be conducted to evaluate the direct effects of DAMPs on immune function.
Who should consider this trial
Good fit: Ideal candidates are infants aged 3 months or younger who are undergoing cardiac surgery with CPB.
Not a fit: Patients who are not undergoing cardiac surgery or are older than 3 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of immune suppression in infants after cardiac surgery.
How similar studies have performed: While the specific approach of measuring DAMPs in this context may be novel, related studies have indicated that understanding immune responses in surgical patients can lead to better outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes
- Nantes University Hospital — Nantes, France (Recruiting)
Study contacts
- Principal investigator: Alexis Chenouard — Nantes University Hospital
- Study coordinator: Alexis Chenouard, ph
- Email: alexis.chenouard@chu-nantes.fr
- Phone: 02.44.76.82.21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.