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Recruiting NCT06840327

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

Observational Cardiac Surgery Extracorporeal Circulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood and tissue samples, walking test.
Who it may be relevant to
Registry conditions: Cardiac Surgery, Extracorporeal Circulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Blood 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.
  • Other walking test
    The study includes a walking test between D5 and D7.

Primary outcome measures

  • Simplified Gravity Index [Time frame: Day 7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • UHToulouse — Toulouse

Identifiers

NCT: NCT06840327 · RC31/24/0523 · ID-RCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗