Protection During Cardiac Surgery.

Thoracic Surgery Clinical Trial

— ProCCard  

Official title:

Protection During Cardiac Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230136
• Other study ID #: 69HCL17_0174
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: July 3, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Thoracic Surgery

Intervention

Other:
• multimodal cardioprotection strategy
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 procedure
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.

Locations

Country	Name	City	State
France	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	Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon	Grenoble
France	Clinique de la sauvegarde	Lyon
France	CHU Saint-Etienne	Saint-Étienne
France	Institut Arnault Tzanck - Saint-Laurent du Var	Saint-Laurent-du-Var

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 72 hours
Secondary	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	30 days
Secondary	Troponin I serum peak value	Highest serum value recorded for each patient within 72 hours	72 hours
Secondary	Troponin I serum value	Serum value recorded for each patient within 24 hours	24 hours
Secondary	Length of mechanical ventilation		30 days
Secondary	Length of stay in intensive care unit (ICU)		30 days
Secondary	Length of stay in hospital		30 days
Secondary	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).	24 hours
Secondary	Number of participants with catecholaminergic support		baseline and 30 days
Secondary	Dose of catecholaminergic support		baseline and 30 days
Secondary	3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)	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.	Baseline and 30 days
Secondary	number of death		30 days