Evaluation of Blood and Cardiac Protein O-GlcNAcylation Levels in Cardiac Surgery in Children

NCT06754709 | Recruiting

• 1 other identifier: RC24_0572
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery requires the use of extracorporeal circulation (ECC). Age-related differences in inflammatory response, the greater susceptibility of immature organ systems to injury and the larger ratio of extracorporeal circuitry to patient size make younger and smaller patients more vulnerable to organ injury. The main problem associated with ECC in neonates and infants is the duration of ECC due to heavier surgeries leading to a prolonged inflammatory state resulting in capillary leak syndrome, low cardiac output syndrome and organ dysfunction, resulting in higher morbidity and mortality. The means of limiting this inflammatory response remain limited. Future studies should aim to address new post-ECC prophylactic targets to improve myocardial and endothelial function. Cardiac metabolism is an important area of research because it plays a central role in maintaining cardiac function under stress. The study of O-GlcNAcylation could therefore be an interesting therapeutic target, given the beneficial role of its stimulation in acute stress situations, as demonstrated in sepsis.

Conditions

Cardiac Surgery; Extracorporeal Circulation; Complications; Metabolism; Low Cardiac Output

Keywords

cardiac surgery; extracorporeal circulation; metabolism; low cardiac output; O-GlcNAcylation,; systemic inflammatory response syndrome

Outcome Measures

Primary Outcomes (1)

• Evaluation of O-GlcNAcylation levels in cardiac surgery in children

  To evaluate the evolution of O-GlcNAcylation levels in pre-per-post extracorporeal circulation in children

  From start of the surgery to 12 hours after start of the surgery

Secondary Outcomes (1)

• Analysis of a potential link between O-GlcNAcylation levels and the prognosis of patients after cardiac surgery

  Up to 6 years after inclusion

Study Arms (1)

Cardiac surgery with extracorporeal circulation

Children aged between 0 and 17 undergoing cardiac surgery with extracorporeal circulation. The children will have blood samples taken at the same time as the samples already taken for all the children as part of the intra- and post-operative management of cardiac surgery. If necessary, the resection of cardiac tissue planned for cardiac surgery will be preserved for the study. Patients' administrative data will be collected at the time of sampling and anonymised. Medical data will be collected retrospectively from the medical record. Patients will be monitored as part of the post-operative cardiac surgery network and data will be collected retrospectively from the patient's file. Western blot analysis (measurement of O-GlcNAcylation) will be carried out as soon as a sufficient number of samples are available in the bio-collection (generally by 15 samples)

Eligibility Criteria

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

Study Population

Children aged between 0 and 17 undergoing cardiac surgery with extracorporeal circulation

You may qualify if:

• Age from 0 to 17 years at the time of sampling
• Children undergoing CEC for cardiac surgery
• Signed bio-collection consent

You may not qualify if:

• Children with an infection
• Children with fever
• Children with an immune deficiency
• Children with autoimmune disease
• Children with metabolic disease
• Children with haematological diseases
• Children with a genetic disease
• Unsigned consent
• Refusal by parents or child

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample, cardiac tissue

MeSH Terms

Conditions

Cardiac Output, Low; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes; Shock

Central Study Contacts

Manon Denis

CONTACT

+33 2 40 08 34 83; manon.denis-med@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): January 31, 2034
• Study Completion (Estimated): January 31, 2035
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

FR (1)