CompletedNot Applicable

Protection During Cardiac Surgery.

France210 participantsStarted 2018-01-03

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I

Timeframe: at 72 hours

Trial details

NCT IDNCT03230136

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-30