SepsisCHANCENCT06754696
Evaluation of Blood Protein O-GlcNAcylation Levels in Children
An observational study of Sepsis and Septic Shock, run by Nantes University Hospital at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock, Development and Health
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2025to 31 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
- Age from 0 to 17 years at the time of sampling (including preterm infants)
Show all 10Show fewer
- 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
Who cannot join
- Children with an infection
- Children with fever
- Children with an immune deficiency
- Children with autoimmune disease
- Children with metabolic disease
- Children with haematological diseases
Show all 17Show fewer
- Children with a genetic disease
- Unsigned consent
- Refusal by parents or child
- Septic group
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44093
Manon Denis, +33 2 40 08 34 83, manon.denis-med@chu-nantes.fr
About this study
Official title: Evaluation of Blood Protein O-GlcNAcylation Levels in Children - CHANCE Study (Child Heart O-glcnAc Nantes)
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.
Read the detailed description
Sepsis is a major but potentially preventable cause of death in children worldwide, with a mortality rate of 29%. It also causes 28% of mild disability and 17% of severe disability in Europe. It is important to note that most studies only look at septic shock in adults, but the populations most affected by septic shock are young children and the elderly. An obvious difficulty in the diagnosis of septic shock in paediatrics is related to the variability of physiological values according to age and the specific pathophysiological features of this pathology in children. Septic shock should be suspected when the child presents with a change in mental status associated with infection and signs of tissue hypoperfusion. Unlike in adults, where septic shock is classically biphasic with an early phase of vasoplegia followed by a phase of low cardiac output, a specific haemodynamic profile is observed in children. It is characterised by severe hypovolemia requiring vascular filling with very heterogeneous responses, low cardiac output and high systemic arterial resistance. In children, septic shock is a dynamic process with heterogeneous haemodynamic phases that change during the course of the shock. The therapeutic agents used and their doses must therefore be adjusted at all times to maintain vascular perfusion. Between 2005 and 2011, more than half of paediatric deaths from septic shock occurred within the first 24 hours. Prompt treatment is a vital factor in the prognosis, with each additional hour spent in shock doubling the risk of death. Unlike in adults, low cardiac output, rather than increased systemic vascular resistance, is associated with mortality. Due to a higher basal heart rate, the increase in heart rate is more limited than in adults. Although the physiopathology of children is different (lower cardiac reserve, lower basal arterial pressure), there are no specific recommendations for children; those for adults are adapted to this population. On the basis of these alarming data, there is a significant socio-economic interest in identifying new treatments for the management of young patients.
Cardiac metabolism is an important area of research because it plays a central role in maintaining cardiac function under stress. In recent years, O-N-acetyl-glucosaminylation, more simply known as O-GlcNAcylation, a post-translational modification of proteins, has attracted considerable interest because it plays a key role in regulating cellular metabolism, but also in the ability to adapt to stress and cell survival. Particular attention has been paid to this metabolic pathway in various pathologies (Alzheimer's disease - patent US20200079766, diabetes, heart attack, etc.) but always in adults or the elderly. The work that investigators have carried out shows that the levels of O-GlcNAcylation of cardiac proteins vary during the early stages of life in rats. This observation is crucial because it could explain some of the metabolic peculiarities of the young heart (use of mainly glycolytic substrates during the first days of life, for example) and the greater capacity of the hearts of newborn rats to withstand stress such as ischaemia-reperfusion. O-GlcNAcylation is a ubiquitous, rapid and reversible post-translational modification involving the addition of a monosaccharide: ß-D-N-acetylglucosamine to the serine and threonine residues of proteins. In physiological conditions, 2 to 3% of the glucose entering the cell is directed towards the hexosamine biosynthesis pathway (VBH), which leads to the production of UDP-GlcNAc used by O-GlcNAc transferase (OGT) to O-GlcNAcylate proteins. The reverse reaction is catalysed by O-GlcNAcase (OGA). VBH is at the crossroads of several cellular metabolic pathways (glucose, acetyl-CoA, glutamine, uridine and ATP) and O-GlcNAcylation is considered to be a metabolic sensor. The number of O-GlcNAcylated targets (+8000 proteins) bears witness to the involvement of this modification in various cellular functions. O-GlcNAc levels are finely modulated according to the cell's metabolic environment, enabling it to adapt to stress. This last point is particularly important as metabolism changes during development, and could have an impact on the hexosamine biosynthesis pathway and therefore on O-GlcNAcylation. Stimulation of O-GlcNAcylation has been shown to be beneficial in several acute pathologies and different animal models. It could therefore be interesting to use this approach in children to limit the impact of various pathologies that induce SIRS, such as extracorporeal circulation for major surgery, septic shock and various traumas.
- Conditions
- Sepsis, Septic Shock, Development and Health, Metabolism Changes
- Keywords
- O-GlcNAcylation, Sepsis, Septic shock, metabolism, children
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of O-GlcNAcylation levels in children
Assess protein O-GlcNAcylation levels as function of age
Measured: 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
Measured: 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
Measured: Up to 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start30 Jan 2025
- Primary completion31 Jan 2036 (estimated)
- Study completion31 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754696
- Sponsor's protocol ID
- RC24_0573
- Acronym
- CHANCE
- Status last verified
- Feb 2025
- First submitted
- 23 Dec 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Protein O-GlcNAcylation Levels in Children - CHANCE Study (Child Heart O-glcnAc Nantes)
- ClinicalTrials.gov ID
- NCT06754696
- Acronym / sponsor ID
- CHANCE / RC24_0573
- Conditions
- Sepsis, Septic Shock, Development and Health, Metabolism Changes
- Keywords
- O-GlcNAcylation, Sepsis, Septic shock, metabolism, children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Jan 2036 (estimated)
- Study completion
- 31 Jan 2036 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis is a major but potentially preventable cause of death in children worldwide, with a mortality rate of 29%. It also causes 28% of mild disability and 17% of severe disability in Europe. It is important to note that most studies only look at septic shock in adults, but the populations most affected by septic shock are young children and the elderly. An obvious difficulty in the diagnosis of septic shock in paediatrics is related to the variability of physiological values according to age and the specific pathophysiological features of this pathology in children. Septic shock should be suspected when the child presents with a change in mental status associated with infection and signs of tissue hypoperfusion. Unlike in adults, where septic shock is classically biphasic with an early phase of vasoplegia followed by a phase of low cardiac output, a specific haemodynamic profile is observed in children. It is characterised by severe hypovolemia requiring vascular filling with very heterogeneous responses, low cardiac output and high systemic arterial resistance. In children, septic shock is a dynamic process with heterogeneous haemodynamic phases that change during the course of the shock. The therapeutic agents used and their doses must therefore be adjusted at all times to maintain vascular perfusion. Between 2005 and 2011, more than half of paediatric deaths from septic shock occurred within the first 24 hours. Prompt treatment is a vital factor in the prognosis, with each additional hour spent in shock doubling the risk of death. Unlike in adults, low cardiac output, rather than increased systemic vascular resistance, is associated with mortality. Due to a higher basal heart rate, the increase in heart rate is more limited than in adults. Although the physiopathology of children is different (lower cardiac reserve, lower basal arterial pressure), there are no specific recommendations for children; those for adults are adapted to this population. On the basis of these alarming data, there is a significant socio-economic interest in identifying new treatments for the management of young patients.
Cardiac metabolism is an important area of research because it plays a central role in maintaining cardiac function under stress. In recent years, O-N-acetyl-glucosaminylation, more simply known as O-GlcNAcylation, a post-translational modification of proteins, has attracted considerable interest because it plays a key role in regulating cellular metabolism, but also in the ability to adapt to stress and cell survival. Particular attention has been paid to this metabolic pathway in various pathologies (Alzheimer's disease - patent US20200079766, diabetes, heart attack, etc.) but always in adults or the elderly. The work that investigators have carried out shows that the levels of O-GlcNAcylation of cardiac proteins vary during the early stages of life in rats. This observation is crucial because it could explain some of the metabolic peculiarities of the young heart (use of mainly glycolytic substrates during the first days of life, for example) and the greater capacity of the hearts of newborn rats to withstand stress such as ischaemia-reperfusion. O-GlcNAcylation is a ubiquitous, rapid and reversible post-translational modification involving the addition of a monosaccharide: ß-D-N-acetylglucosamine to the serine and threonine residues of proteins. In physiological conditions, 2 to 3% of the glucose entering the cell is directed towards the hexosamine biosynthesis pathway (VBH), which leads to the production of UDP-GlcNAc used by O-GlcNAc transferase (OGT) to O-GlcNAcylate proteins. The reverse reaction is catalysed by O-GlcNAcase (OGA). VBH is at the crossroads of several cellular metabolic pathways (glucose, acetyl-CoA, glutamine, uridine and ATP) and O-GlcNAcylation is considered to be a metabolic sensor. The number of O-GlcNAcylated targets (+8000 proteins) bears witness to the involvement of this modification in various cellular functions. O-GlcNAc levels are finely modulated according to the cell's metabolic environment, enabling it to adapt to stress. This last point is particularly important as metabolism changes during development, and could have an impact on the hexosamine biosynthesis pathway and therefore on O-GlcNAcylation. Stimulation of O-GlcNAcylation has been shown to be beneficial in several acute pathologies and different animal models. It could therefore be interesting to use this approach in children to limit the impact of various pathologies that induce SIRS, such as extracorporeal circulation for major surgery, septic shock and various traumas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- Septic group
- Children with an immune deficiency
- Children with autoimmune disease
- Children with a metabolic disease
- Children with haematological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of O-GlcNAcylation levels in children
Time frame: At inclusion
Assess protein O-GlcNAcylation levels as function of age
Assess the impact of septic shock on O-GlcNAcylation levels: - Comparison of O-GlcNAcylation levels between healthy patients and patients in septic shock
Time frame: Between inclusion and 48 hours after inclusion
Comparison of O-GlcNAcylation levels between healthy patients and patients in septic shock
1 secondary outcome
Analysis of a potential link between O-GlcNAcylation levels and the prognosis of patients in septic shock
Time frame: Up to 5 years after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon Denis, MD (+33 2 40 08 34 83, manon.denis-med@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of O-GlcNAcylation levels in children (time frame: At inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.