Evaluation of Blood Protein O-GlcNAcylation Levels in Children

NCT06754696 | Recruiting

• 1 other identifier: RC24_0573
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Stimulation of O-GlcNAcylation has been shown to be beneficial in several acute pathologies and different animal models, such as haemorrhagic and septic shock, and ischaemia-reperfusion (cerebral and cardiac). It could therefore be interesting to use this approach in children in order to limit the impact of various pathologies inducing SIRS, such as extracorporeal circulation for major surgery, septic shock or various traumas. The investigators demonstrated in 2 different animal models (endotoxemia by injection of Lipopolysaccharides and caecal puncture ligation model) with 3 different pharmacological molecules (Glucosamine, ThiametG and NButGT) that stimulation of O-GlcNAcylation was beneficial in the early phase of septic shock with a marked effect on cardiac function and survival. The investigators thus demonstrated that stimulation of O-GlcNAcylation was beneficial in young rats in septic shock. However, none of this work has yet been reproduced in humans, either children or adults.

Conditions

Sepsis; Septic Shock; Development and Health; Metabolism Changes

Keywords

O-GlcNAcylation; Sepsis; Septic shock; metabolism; children

Outcome Measures

Primary Outcomes (2)

• Evaluation of O-GlcNAcylation levels in children

  Assess protein O-GlcNAcylation levels as function of age

  At inclusion

• Assess the impact of septic shock on O-GlcNAcylation levels: - Comparison of O-GlcNAcylation levels between healthy patients and patients in septic shock

  Comparison of O-GlcNAcylation levels between healthy patients and patients in septic shock

  Between inclusion and 48 hours after inclusion

Secondary Outcomes (1)

• Analysis of a potential link between O-GlcNAcylation levels and the prognosis of patients in septic shock

  Up to 5 years after inclusion

Study Arms (2)

Healthy group

children attending hospital and receiving a blood sample as part of their care during general paediatric consultations, anaesthesia or day hospital consultations. Children requiring a blood test as part of a medical indication in the first week of life / blood samples taken at birth from cord blood. A blood sample will be taken at inclusion during a blood test carried out in the care unit, and possibly if other blood samples are planned as part of the care, additional samples will be taken in a maximum of 6 tubes in 48 hours, i.e. for a total volume of 600 µl to 3 ml. The child's clinical data will be collected in his medical file.

Septic shock

Children attending a paediatric emergency department for a severe infection requiring vascular filling, or a child admitted to an intensive care unit for sepsis or presenting with sepsis during hospitalisation. A blood sample will be taken at inclusion during a blood test carried out in the care unit and then at H3, H6, H12, H24 and H48, i.e. 6 times in 48 hours for a total volume of 600 µl to 3 ml for patients in septic shock. The child's clinical data will be collected in his medical file.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children attending hospital and receiving a blood sample as part of their care during general paediatric consultations, anaesthesia or day hospital consultations. Children attending a paediatric emergency department for a severe infection requiring vascular filling, or a child admitted to an intensive care unit for sepsis or presenting with sepsis during hospitalization

You may qualify if:

• Age from 0 to 17 years at the time of sampling (including premature infants)
• Children coming to hospital for a blood sample to be taken as part of a pre-operative check-up, an allergy check-up or a check-up as part of a pathology other than sepsis.
• Premature infants benefiting from a blood sample as part of their monitoring and management of prematurity
• Collection of umbilical cord blood
• Signed 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
• Septic group
• Age from 0 to 17 years at the time of sampling (including preterm infants)
• Children with suspected sepsis or diagnosed sepsis according to the 2016 definition
• Premature infants having blood drawn for suspected or diagnosed sepsis
• All responsible bacteria, viruses or fungi
• Signed bio-collection consent

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Manon Denis, MD

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: January 30, 2025
• Primary Completion (Estimated): January 31, 2036
• Study Completion (Estimated): January 31, 2036
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

FR (1)