IMMUNOPED2: Plasma Levels of Danger-Associated Molecular Patterns in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04423523
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 26.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgical Procedure

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)
• Actual Study Start Date: Sep 2, 2020
• Anticipated Primary Completion Date: May 11, 2022
• Anticipated Study Completion Date: Nov 11, 2022

Outcome Measures

Primary Outcome Measures

1. 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]

   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 Outcome Measures

1. Effect of DAMPs on immune function:In vitro change of HLA-DR expression. [6 hours after surgery]

   In vitro change of HLA-DR expression induced by plasma containing different concentrations of DAMPs.

2. Effect of DAMPs on immune function:Secretion of IL-10 ( Interleukine 10). [6 hours after surgery]

   Secretion of IL-10 by different immune cells induced by plasma containing different concentrations of DAMPs.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 3 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients ≤ 3 months undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Lack of parental consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Alexis Chenouard, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT04423523
• Other Study ID Numbers: RC19_0402
• First Posted: Jun 9, 2020
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nantes University Hospital: cardiopulmonary bypass; immunosuppression; infant; immunosuppression; infant

Study Results

No Results Posted as of Sep 13, 2021