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RecruitingNCT06840327VARIOXYUpdated Jun 29, 2026

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

An observational study in Cardiac Surgery and Extracorporeal Circulation, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by University Hospital, Toulouse · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Cardiac Surgery
  • Extracorporeal Circulation

Keywords

  • extracorporeal circulation
  • cardiac surgery
  • biological markers
  • Redox balance
  • post-operative outcome
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In context

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing scheduled cardiac surgery under CEC for coronary bypass surgery with saphenous vein harvesting at Toulouse University Hospital

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

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Scheduled cardiac surgery patients

    Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting.

    Other: Blood and tissue samples · Other: walking test

Interventions

  • OtherBlood and tissue samples

    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.

  • Otherwalking test

    The study includes a walking test between D5 and D7.

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What researchers measure

Primary outcomes

  1. 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 )

    Time frame: Day 7

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Study locations

1 of 1 sites recruiting
  • UHToulouse
    Toulouse, France
    • François LABASTE, MCU-PH · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06840327
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Feb 21, 2025
Start date
Oct 7, 2025
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

François LABASTE, MD-PH
Contact
labaste.f@chu-toulouse.fr
05 61 32 28 22 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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