Clinical trial NCT03230136: Protection During Cardiac Surgery.
Official title: Protection During Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Cardiopulmonary Bypass
Keywords: Myocardial injury
Ischemia reperfusion
cardiac surgery
cardioprotection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I
timeFrame: at 72 hours
Secondary outcomes:
measure: Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy
timeFrame: 30 days
measure: Troponin I serum peak value
timeFrame: 72 hours
measure: Troponin I serum value
timeFrame: 24 hours
measure: Length of mechanical ventilation
timeFrame: 30 days
measure: Length of stay in intensive care unit (ICU)
timeFrame: 30 days
measure: Length of stay in hospital
timeFrame: 30 days
measure: Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)
timeFrame: 24 hours
measure: Number of participants with catecholaminergic support
timeFrame: baseline and 30 days
measure: Dose of catecholaminergic support
timeFrame: baseline and 30 days
measure: 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
timeFrame: Baseline and 30 days
measure: number of death
timeFrame: 30 days
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH Annecy
city: Bron
country: France
facility: Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: service de Chirurgie Cardiaque CHU Gabriel Montpied
city: Grenoble
country: France
facility: Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon
city: Lyon
country: France
facility: Clinique de la sauvegarde
city: Saint-Laurent-du-Var
country: France
facility: Institut Arnault Tzanck - Saint-Laurent du Var
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-Luc FELLAHI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiari P, Mewton N, Maucort-Boulch D, Desebbe O, Durand M, Fischer MO, Lena-Quintard D, Palao JC, Ovize M, Fellahi JL. Multimodal Strategy for Myocardial Protection During Cardiac Surgery: The ProCCard Study. J Am Coll Cardiol. 2021 Feb 16;77(6):827-829. doi: 10.1016/j.jacc.2020.12.020. No abstract available.
citation: Chiari P, Durand M, Desebbe O, Fischer MO, Lena-Quintard D, Palao JC, Mercier C, Samson G, Varillon Y, Pozzi M, Mewton N, Maucort-Boulch D, Ovize M, Fellahi JL. Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial. Trials. 2019 Sep 11;20(1):560. doi: 10.1186/s13063-019-3638-3.