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

NCT ID: NCT06840327

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Cardiac Surgery Extracorporeal Circulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Scheduled cardiac surgery patients

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

Blood and tissue samples

Intervention Type OTHER

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 test

Intervention Type OTHER

The study includes a walking test between D5 and D7.

Interventions

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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.

Intervention Type OTHER

walking test

The study includes a walking test between D5 and D7.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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François LABASTE, MD-PH

Role: CONTACT

05 61 32 28 22 ext. +33

Other Identifiers

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ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/24/0523

Identifier Type: -

Identifier Source: org_study_id

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