Protection During Cardiac Surgery. (ProCCard)

Civil Hospices of Lyon

Status: Completed

Conditions: Cardiopulmonary Bypass; Thoracic Surgery

Treatments: Other: standard anesthetic procedure; Other: multimodal cardioprotection strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03230136

69HCL17_0174

Details and patient eligibility

About

This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Multimodal cardioprotection therapeutic strategy

Experimental group

Treatment:

Other: multimodal cardioprotection strategy

Traditional anesthetic and therapeutic

Active Comparator group

Description:

standard anesthetic procedure No intervention (Control).

Treatment:

Other: standard anesthetic procedure