NCT06754696 Evaluation of Blood Protein O-GlcNAcylation Levels in Children
| NCT ID | NCT06754696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2036-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2025-01-30 with a primary completion date of 2036-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
1. Healthy group Inclusion Criteria : * 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 Exclusion Criteria : * 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 2. Septic group Inclusion Criteria : * 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 Exclusion Criteria : * Children with an immune deficiency * Children with autoimmune disease * Children with a metabolic disease * Children with haematological diseases * Children with a genetic disease * Unsigned bio-collection consent * Refusal by parents or child
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06754696 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06754696 currently recruiting?
Yes, NCT06754696 is actively recruiting participants. Contact the research team at manon.denis-med@chu-nantes.fr for enrollment information.
Where is the NCT06754696 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT06754696 clinical trial?
NCT06754696 is sponsored by Nantes University Hospital. The trial plans to enroll 240 participants.