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Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome

Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06840327
Acronym
VARIOXY
Enrollment
120
Registered
2025-02-21
Start date
2025-03-31
Completion date
2027-06-30
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Extracorporeal Circulation

Keywords

extracorporeal circulation, cardiac surgery, biological markers, Redox balance, post-operative outcome

Brief summary

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.

Interventions

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.

The study includes a walking test between D5 and D7.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Emergency surgery patients. Pregnant or breast-feeding women. Patients deprived of their freedom or under legal protective measures.

Design outcomes

Primary

MeasureTime frameDescription
Simplified Gravity IndexDay 7severity 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 )

Contacts

Primary ContactFrançois LABASTE, MD-PH
labaste.f@chu-toulouse.fr05 61 32 28 22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026