Protection During Cardiac Surgery.

NCT03230136 | Completed DMC

• 1 other identifier: 69HCL17_0174
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 8

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.

Conditions

Cardiopulmonary Bypass; Thoracic Surgery

Keywords

Myocardial injury; Ischemia reperfusion; cardiac surgery; cardioprotection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  30 days

• Troponin I serum peak value

  72 hours

• Troponin I serum value

  24 hours

• Length of mechanical ventilation

  30 days

• Length of stay in intensive care unit (ICU)

  30 days

Study Arms (2)

Multimodal cardioprotection therapeutic strategy

EXPERIMENTAL

Other: multimodal cardioprotection strategy

Traditional anesthetic and therapeutic

ACTIVE COMPARATOR

standard anesthetic procedure No intervention (Control).

Other: standard anesthetic procedure

Interventions

multimodal cardioprotection strategy OTHER

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).

Multimodal cardioprotection therapeutic strategy

standard anesthetic procedure OTHER

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.

Traditional anesthetic and therapeutic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (8)

CH Annecy

Annecy, France

Location

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

Bron, 69500, France

Location

CHU de Caen

Caen, France

Location

service de Chirurgie Cardiaque CHU Gabriel Montpied

Clermont-Ferrand, France

Location

Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon

Grenoble, France

Location

Clinique de la sauvegarde

Lyon, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

Institut Arnault Tzanck - Saint-Laurent du Var

Saint-Laurent-du-Var, France

Location

Related Publications (2)

• 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.

  PMID: 31511041 RESULT

• 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.

  PMID: 33573748 RESULT

Study Officials

• Jean-Luc FELLAHI

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: January 3, 2018
• Primary Completion: May 30, 2019
• Study Completion: July 3, 2019
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (8)