Protection During Cardiac Surgery.

Not Applicable

Completed

• Conditions: Thoracic Surgery; Cardiopulmonary Bypass
• Interventions: Other: multimodal cardioprotection strategy; Other: standard anesthetic procedure

• Registration Number: NCT03230136
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-26
• Study Start: 2018-01-03
• Primary Completion: 2019-05-30
• Study Completion: 2019-07-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-03
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal cardioprotection therapeutic strategy	multimodal cardioprotection strategy	-
Traditional anesthetic and therapeutic	standard anesthetic procedure	standard anesthetic procedure No intervention (Control).

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I	at 72 hours	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.

Secondary Outcome Measures

Name	Time	Method
Length of mechanical ventilation	30 days
3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)	Baseline and 30 days	The 3-level version of EQ-5D consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Length of stay in intensive care unit (ICU)	30 days
Number of participants with catecholaminergic support	baseline and 30 days
Dose of catecholaminergic support	baseline and 30 days
Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy	30 days	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
Troponin I serum peak value	72 hours	Highest serum value recorded for each patient within 72 hours
Length of stay in hospital	30 days
Troponin I serum value	24 hours	Serum value recorded for each patient within 24 hours
Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)	24 hours	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).
number of death	30 days

Trial Locations

Locations (8)

CH Annecy; 🇫🇷 Annecy, France

Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel; 🇫🇷 Bron, France

CHU de Caen; 🇫🇷 Caen, France

Clinique de la sauvegarde; 🇫🇷 Lyon, France

service de Chirurgie Cardiaque CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon; 🇫🇷 Grenoble, France

Institut Arnault Tzanck - Saint-Laurent du Var; 🇫🇷 Saint-Laurent-du-Var, France

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France