Cardiac SurgeryVARIOXYNCT06840327
Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome
An observational study of Cardiac Surgery and Extracorporeal Circulation, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Observational, prospective, monocentric study conducted in the cardiac surgery department about biological markers to predict the short-term outcome of heart surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Extracorporeal Circulation
- What is being tested?
- Blood and tissue samples and walking test
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2025to Oct 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing scheduled cardiac surgery under CEC for coronary bypass surgery with saphenous vein harvesting at Toulouse University Hospital
Who may be able to join
- Patients over 18 years of age Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting.
- Patients able to understand the protocol; Patients able to express non-opposition to participating in the study Patients affiliated to a social security system or equivalent.
Who cannot join
- Emergency surgery patients. Pregnant or breast-feeding women. Patients deprived of their freedom or under legal protective measures.
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
UHToulouse
Toulouse
François LABASTE, MCU-PH
About this study
Observational, prospective, monocentric study conducted in the cardiac surgery department about biological markers to predict the short-term outcome of heart surgery patients.
Read the detailed description
At present, there are no biological markers to predict the short-term outcome of heart surgery patients. Redox balance, determined by the interaction between oxidants and reducers in tissues, is an essential parameter in the regulation of cellular functions. Cardiac surgery with extracorporeal circulation (CEC) induces major disturbances in this balance. In preliminary work, it was observed that the redox potential (Eg) varied with the introduction of CEC, and a persistent imbalance appeared to correlate with post-operative complications. It is believed that Eg potential could be a new biomarker of the post-operative outcome of major surgery.
- Conditions
- Cardiac Surgery, Extracorporeal Circulation
- Being tested
- Blood and tissue samples, walking test
- Keywords
- extracorporeal circulation, cardiac surgery, biological markers, Redox balance, post-operative outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and tissue samplesOther
Blood samples will be taken from catheters placed for the purpose of surgery (arterial and venous catheters), or during routine venipunctures. (D-1 pre-op). Tissue samples will be taken from surgical waste generated by the surgery. They will therefore not require any additional incisions or surgical procedures.
walking testOther
The study includes a walking test between D5 and D7.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled cardiac surgery patients | Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting. Receives: Other: Blood and tissue samples; Other: walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simplified Gravity Index
severity score used in intensive care to assess the risk of in-hospital mortality. Score from 0 to 163 points (0 is the best possible state of health / 163 is the worst possible state of health )
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start7 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (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 University Hospital, ToulouseThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840327
- Sponsor's protocol ID
- RC31/24/0523
- Other IDs
- ID-RCB
- Acronym
- VARIOXY
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome
- ClinicalTrials.gov ID
- NCT06840327
- Acronym / sponsor ID
- VARIOXY / RC31/24/0523
- Conditions
- Cardiac Surgery, Extracorporeal Circulation
- Keywords
- extracorporeal circulation, cardiac surgery, biological markers, Redox balance, post-operative outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Feb 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.
Observational, prospective, monocentric study conducted in the cardiac surgery department about biological markers to predict the short-term outcome of heart surgery patients.
Detailed description
At present, there are no biological markers to predict the short-term outcome of heart surgery patients. Redox balance, determined by the interaction between oxidants and reducers in tissues, is an essential parameter in the regulation of cellular functions. Cardiac surgery with extracorporeal circulation (CEC) induces major disturbances in this balance. In preliminary work, it was observed that the redox potential (Eg) varied with the introduction of CEC, and a persistent imbalance appeared to correlate with post-operative complications. It is believed that Eg potential could be a new biomarker of the post-operative outcome of major surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scheduled cardiac surgery patients | – | Other: Blood and tissue samples, Other: walking testScheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled cardiac surgery under CEC for coronary bypass surgery with saphenous vein harvesting at Toulouse University Hospital
Key inclusion criteria (2 listed)
- Patients over 18 years of age Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting.
- Patients able to understand the protocol; Patients able to express non-opposition to participating in the study Patients affiliated to a social security system or equivalent.
Key exclusion criteria (1 listed)
- Emergency surgery patients. Pregnant or breast-feeding women. Patients deprived of their freedom or under legal protective measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and tissue samplesBlood samples will be taken from catheters placed for the purpose of surgery (arterial and venous catheters), or during routine venipunctures. (D-1 pre-op). Tissue samples will be taken from surgical waste generated by the surgery. They will therefore not require any additional incisions or surgical procedures. | Other | Scheduled cardiac surgery patients |
| walking testThe study includes a walking test between D5 and D7. | Other | Scheduled cardiac surgery patients |
Primary outcome
Simplified Gravity Index
Time frame: Day 7
severity score used in intensive care to assess the risk of in-hospital mortality. Score from 0 to 163 points (0 is the best possible state of health / 163 is the worst possible state of health )
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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, run by University Hospital, Toulouse 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 2 inclusion and 1 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 29 Jun 2026. 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 François LABASTE, MD-PH (05 61 32 28 22 ext. +33, labaste.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simplified Gravity Index (time frame: Day 7). 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 29 Jun 2026.