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

NCT06840327 | Not Yet Recruiting

• 2 other identifiers: RC31/24/0523ID-RCB
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Surgery; Extracorporeal Circulation

Keywords

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

Outcome Measures

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 )

  Day 7

Study Arms (1)

Scheduled cardiac surgery patients

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

Other: Blood and tissue samples; Other: walking test

Interventions

Blood and tissue samples 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.

Scheduled cardiac surgery patients

walking test OTHER

The study includes a walking test between D5 and D7.

Scheduled cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical residue from incision surgery planned for surgery without additional incision; catheter samples: peripheral venous blood, central venous blood, peripheral arterial blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

François LABASTE, MD-PH

CONTACT

05 61 32 28 22; labaste.f@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share