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Protection During Cardiac Surgery.

NCT ID: NCT03230136

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2019-07-03

Brief Summary

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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

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Conditions

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Thoracic Surgery Cardiopulmonary Bypass

Keywords

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Myocardial injury Ischemia reperfusion cardiac surgery cardioprotection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Multimodal cardioprotection therapeutic strategy

Group Type EXPERIMENTAL

multimodal cardioprotection strategy

Intervention Type 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).

Traditional anesthetic and therapeutic

standard anesthetic procedure No intervention (Control).

Group Type ACTIVE_COMPARATOR

standard anesthetic procedure

Intervention Type 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.

Interventions

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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).

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc FELLAHI

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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CH Annecy

Annecy, , France

Site Status

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

Bron, , France

Site Status

CHU de Caen

Caen, , France

Site Status

service de Chirurgie Cardiaque CHU Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon

Grenoble, , France

Site Status

Clinique de la sauvegarde

Lyon, , France

Site Status

CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Institut Arnault Tzanck - Saint-Laurent du Var

Saint-Laurent-du-Var, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 31511041 (View on PubMed)

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.

Reference Type RESULT
PMID: 33573748 (View on PubMed)

Other Identifiers

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69HCL17_0174

Identifier Type: -

Identifier Source: org_study_id