Cardiac SurgeryCardiOGlcNAcNCT06754709
Evaluation of Blood and Cardiac Protein O-GlcNAcylation Levels in Cardiac Surgery in Children
An observational study of Cardiac Surgery and Extracorporeal Circulation; Complications, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Cardiac Surgery, Extracorporeal Circulation; Complications, Metabolism
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2025to 31 Jan 2035
- 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
- No healthy volunteers
- Child
Study population: Children aged between 0 and 17 undergoing cardiac surgery with extracorporeal circulation
Who may be able to join
- Age from 0 to 17 years at the time of sampling
- Children undergoing CEC for cardiac surgery
- 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 9Show fewer
- Children with a genetic disease
- Unsigned 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
Manon Denis, +33 2 40 08 34 83, manon.denis-med@chu-nantes.fr
About this study
Official title: Evaluation of the Levels of O-GlcNAcylation of Cardiac and Blood Proteins in Paediatric Cardiac Surgery and Identification of Therapeutic Targets
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.
Read the detailed description
Extracorporeal circulation (ECC) is a circuit that provides circulatory assistance to facilitate surgical access to a bloodless and, in some cases (in the case of cardioplegia) immobile operating field. This strategy has led to technical and procedural advances in cardiothoracic surgery that would have been unthinkable without bypass surgery. ECC leads to systemic inflammatory response syndrome and is associated with postoperative complications, including myocardial dysfunction, respiratory failure, acute renal failure, neurological dysfunction, coagulation disorders and, finally, multivisceral failure. Numerous data suggest that inflammation and oxidative stress occur shortly after the start of bypass surgery and progress over time. ECC-induced SIRS, similar to sepsis, leads to stimulation and activation of endothelial cells. Circulating pro-inflammatory cytokines can also directly stimulate endothelial cells, resulting in a pathological increase in permeability leading to the development of capillary leak syndrome, causing tissue oedema and impaired oxygen utilisation leading to multiple organ dysfunctions. Clinical practice has shown that the majority of infants suffer haemodynamic failure within 4 to 8 hours of the operation. This failure could be related to a state of vasodilatation (capillary leakage) and/or a low cardiac output syndrome. The timing of the onset of this failure correlates with peak cytokine secretion. The risk factors for severe SIRS in paediatric cardiac surgery are low weight, heart disease with an intra-cardiac right-left shunt, the duration of aortic clamping and the length of the bypass operation. This state of vasoplegia is associated with an increase in lactate production, reflecting an imbalance between organ oxygen demand and supply, an increase in amine requirements and an increase in invasive ventilation time. In many cases, vasoplegia is associated with low cardiac output syndrome. This syndrome is the most common post-operative complication in paediatric cardiac surgery. Twenty-five to sixty per cent of newborns develop low cardiac output syndrome (LCOS) in the 6 to 18 hours following surgery, with mortality occurring in 20% of cases. Current means of limiting post-CEC SIRS remain limited. The understanding of inflammatory processes and the interaction between humoral factors and the cellular immune response has progressed rapidly over the last decade. Multiple anti-inflammatory strategies have been applied in the past, significantly reducing cytokine levels without improving clinical outcome. This means that the amplitude of inflammatory cytokine secretion does not directly predict patient outcome. Future studies should aim to address new post-CEC 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. In recent years, there has been considerable interest in O-GlcNAcylation, a post-translational modification of proteins, as it plays a key role in regulating cellular metabolism and the ability to adapt to stress and cell survival. O-N-acetyl glucosaminylation, more simply known as 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, some 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 (+3000 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 during CEC, which impacts the hexosamine biosynthesis pathway and therefore O-GlcNAcylation. O-GlcNAcylation is particularly difficult to study at cardiac level, but the investigators have shown that there is a close correlation between blood (whole blood) and cardiac O-GlcNAc levels in rats. Preliminary data in rats have shown that O-GlcNAcylation levels decrease during bypass surgery and that there is an interest in increasing O-GlcNAcylation levels during bypass surgery in order to reduce organ failure, but no human data have been published in this context.
- 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
- Medical subject headings
- Cardiac Output, Low, Systemic Inflammatory Response Syndrome
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 |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To study the correlation between blood and cardiac O-GlcNAcylation levels and patient prognosis
Measured: Up to 6 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 start13 Feb 2025
- Primary completion31 Jan 2034 (estimated)
- Study completion31 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- 300 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
- NCT06754709
- Sponsor's protocol ID
- RC24_0572
- Acronym
- CardiOGlcNAc
- Status last verified
- Apr 2025
- First submitted
- 23 Dec 2024
- Last updated
- 13 Apr 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Levels of O-GlcNAcylation of Cardiac and Blood Proteins in Paediatric Cardiac Surgery and Identification of Therapeutic Targets
- ClinicalTrials.gov ID
- NCT06754709
- Acronym / sponsor ID
- CardiOGlcNAc / RC24_0572
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 31 Jan 2034 (estimated)
- Study completion
- 31 Jan 2035 (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.
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.
Detailed description
Extracorporeal circulation (ECC) is a circuit that provides circulatory assistance to facilitate surgical access to a bloodless and, in some cases (in the case of cardioplegia) immobile operating field. This strategy has led to technical and procedural advances in cardiothoracic surgery that would have been unthinkable without bypass surgery. ECC leads to systemic inflammatory response syndrome and is associated with postoperative complications, including myocardial dysfunction, respiratory failure, acute renal failure, neurological dysfunction, coagulation disorders and, finally, multivisceral failure. Numerous data suggest that inflammation and oxidative stress occur shortly after the start of bypass surgery and progress over time. ECC-induced SIRS, similar to sepsis, leads to stimulation and activation of endothelial cells. Circulating pro-inflammatory cytokines can also directly stimulate endothelial cells, resulting in a pathological increase in permeability leading to the development of capillary leak syndrome, causing tissue oedema and impaired oxygen utilisation leading to multiple organ dysfunctions. Clinical practice has shown that the majority of infants suffer haemodynamic failure within 4 to 8 hours of the operation. This failure could be related to a state of vasodilatation (capillary leakage) and/or a low cardiac output syndrome. The timing of the onset of this failure correlates with peak cytokine secretion. The risk factors for severe SIRS in paediatric cardiac surgery are low weight, heart disease with an intra-cardiac right-left shunt, the duration of aortic clamping and the length of the bypass operation. This state of vasoplegia is associated with an increase in lactate production, reflecting an imbalance between organ oxygen demand and supply, an increase in amine requirements and an increase in invasive ventilation time. In many cases, vasoplegia is associated with low cardiac output syndrome. This syndrome is the most common post-operative complication in paediatric cardiac surgery. Twenty-five to sixty per cent of newborns develop low cardiac output syndrome (LCOS) in the 6 to 18 hours following surgery, with mortality occurring in 20% of cases. Current means of limiting post-CEC SIRS remain limited. The understanding of inflammatory processes and the interaction between humoral factors and the cellular immune response has progressed rapidly over the last decade. Multiple anti-inflammatory strategies have been applied in the past, significantly reducing cytokine levels without improving clinical outcome. This means that the amplitude of inflammatory cytokine secretion does not directly predict patient outcome. Future studies should aim to address new post-CEC 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. In recent years, there has been considerable interest in O-GlcNAcylation, a post-translational modification of proteins, as it plays a key role in regulating cellular metabolism and the ability to adapt to stress and cell survival. O-N-acetyl glucosaminylation, more simply known as 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, some 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 (+3000 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 during CEC, which impacts the hexosamine biosynthesis pathway and therefore O-GlcNAcylation. O-GlcNAcylation is particularly difficult to study at cardiac level, but the investigators have shown that there is a close correlation between blood (whole blood) and cardiac O-GlcNAc levels in rats. Preliminary data in rats have shown that O-GlcNAcylation levels decrease during bypass surgery and that there is an interest in increasing O-GlcNAcylation levels during bypass surgery in order to reduce organ failure, but no human data have been published in this context.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged between 0 and 17 undergoing cardiac surgery with extracorporeal circulation
Key inclusion criteria (3 listed)
- Age from 0 to 17 years at the time of sampling
- Children undergoing CEC for cardiac surgery
- Signed bio-collection consent
Key exclusion criteria (9 listed)
- Children with an infection
- Children with fever
- Children with an immune deficiency
- Children with autoimmune disease
- Children with metabolic disease
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 cardiac surgery in children
Time frame: From start of the surgery to 12 hours after start of the surgery
To evaluate the evolution of O-GlcNAcylation levels in pre-per-post extracorporeal circulation in children
1 secondary outcome
Analysis of a potential link between O-GlcNAcylation levels and the prognosis of patients after cardiac surgery
Time frame: Up to 6 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 Apr 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 Cardiac Surgery and Extracorporeal Circulation; Complications, 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 3 inclusion and 9 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 Apr 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 (+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 cardiac surgery in children (time frame: From start of the surgery to 12 hours after start of the surgery). 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 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.