Protection During Cardiac Surgery.

Hospices Civils de Lyon210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

210

Conditions

Thoracic Surgery Cardiopulmonary Bypass

Interventions

multimodal cardioprotection strategyOTHER

Multimodal cardioprotection therapeutic strategy will include (1) remote ischemic preconditioning, (2) volatile anesthetic sevoflurane-induced preconditioning, (3) blood glucose control every 30 minutes during cardiac surgery, (4) temporary respiratory acidosis prior to the aortic cross-unclamping and (5) gradual restoration of blood flow after aortic cross-unclamping (gentle reperfusion).

standard anesthetic procedureOTHER

standard anesthetic procedure will include: anesthesia under propofol throughout the cardiac surgery, blood glucose control every 60 minutes, arterial pH maintained at 7.40, theoric blood flow restored at the earliest after aortic cross-unclamping.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

CH Annecy

Annecy, France

Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel

Bron, France

CHU de Caen

Caen, France

service de Chirurgie Cardiaque CHU Gabriel Montpied

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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

Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I determined for each patient with the serial measurement from of troponin I assays.

Time frame: at 72 hours

Secondary Outcomes

Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy

Adverse events will include death, myocardial infarction, heart failure,arrhythmia requiring medical therapy, neurological disorder such as stroke,respiratory insufficiency, any infectious event, major bleeding requiring transfusion of ≥ 5 U packed red blood cells or surgical intervention or surgical complication

Time frame: 30 days

Troponin I serum peak value

Highest serum value recorded for each patient within 72 hours

Time frame: 72 hours

Troponin I serum value

Serum value recorded for each patient within 24 hours

Time frame: 24 hours

Length of mechanical ventilation

Time frame: 30 days

Length of stay in intensive care unit (ICU)

Time frame: 30 days

Length of stay in hospital

Time frame: 30 days

Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)

Index Gravity Score provides an estimate of the risk of death: the higher the score is, the higher the risk to die is. The maximum score is 163. The Index Gravity Score includes 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy).

Data from ClinicalTrials.gov

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