Status:
COMPLETED
Protection During Cardiac Surgery.
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Thoracic Surgery
Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management....
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Aortic valve surgery (aortic valve replacement associated or not with coronary artery bypass graft, Bentall surgery or Tirone David surgery)
- Signed informed consent
Exclusion
- Emergency surgery
- Redo surgery
- Patient treated with Nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery
- Low cardiac output requiring catecholamine infusion or circulatory assistance prior to surgery
- Severe renal failure: dialysis or glomerular filtration rate \< 30 mL/min
- Severe liver failure (spontaneous INR \>2)
- Severe respiratory insufficiency (VEMS \<40% of predicted value)
- Contra-indication to sevoflurane and propofol
- Myocardial infarction \< 7 days
- Severe upper limb arterial disease
- Heparin-induced thrombopenia
- Active infection under antibiotic treatment
- Any other surgery combined with the aortic valve surgery: myotomia of Morrow (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial communication closure, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement.
- Pregnant women
- Currently participating in another trial which may interfere with ProCCard results
- Not benefiting from a social insurance or similar system
- Patient under legal protection
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2019
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03230136
Start Date
January 3 2018
End Date
July 3 2019
Last Update
December 19 2025
Active Locations (8)
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1
CH Annecy
Annecy, France
2
Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel
Bron, France, 69500
3
CHU de Caen
Caen, France
4
service de Chirurgie Cardiaque CHU Gabriel Montpied
Clermont-Ferrand, France