Evaluation of Blood Protein O-GlcNAcylation Levels in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorNantes University Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Healthy group

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

Disqualifiers

Children with an infection

Children with fever

Children with an immune deficiency

Children with autoimmune disease

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

240 Participants
are grouped into 2 trial groups
Group A: Healthy group
Group B: Septic shock

Trial outcomes

Primary outcomes

1

Evaluation of O-GlcNAcylation levels in children

Assess protein O-GlcNAcylation levels as function of age

Time frame
At inclusion
2

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

Time frame
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

Study of the correlation between O-GlcNAcylation levels and the prognosis of patients in septic shock

Time frame
Up to 5 years after inclusion

Other outcomes

Sponsors and contacts

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