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01.12.2019 | Study protocol | Ausgabe 1/2019 Open Access

Trials 1/2019

Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2019
Autoren:
Pascal Chiari, Michel Durand, Olivier Desebbe, Marc-Olivier Fischer, Diane Lena-Quintard, Jean-Charles Palao, Catherine Mercier, Géraldine Samson, Yvonne Varillon, Matteo Pozzi, Nathan Mewton, Delphine Maucort-Boulch, Michel Ovize, Jean-Luc Fellahi
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Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-019-3638-3) contains supplementary material, which is available to authorized users.

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Abstract

Background

Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single aspect of cardioprotection have shown conflicting results. We tested the hypothesis that a multimodal approach would improve cardioprotection and limit myocardial damage following cardiac surgery with cardiopulmonary bypass.

Methods

This study is a pragmatic multicenter (six French institutions), prospective, randomized, single-blinded, controlled trial. The randomization is stratified by centers. In the study, 210 patients scheduled for aortic valve surgery with or without coronary artery bypass grafting will be assigned to a control or a treatment group (105 patients in each group). In the control group, patients receive total intravenous anesthesia with propofol and liberal intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 60 min, is greater than 180 mg/dl), as a standard of care. The treatment group receives a bundle of care combining five techniques of cardioprotection: (1) remote ischemic preconditioning applied before aortic cross-clamping; (2) maintenance of anesthesia with sevoflurane; (3) tight intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 30 min, is greater than 140 mg/dl); (4) moderate respiratory acidosis (pH 7.30) at the end of cardiopulmonary bypass; and (5) a gentle reperfusion protocol following aortic unclamping. The primary outcome is myocardial damage measured by postoperative 72-h area under the curve of high-sensitivity cardiac troponin I.

Discussion

The ProCCard study will be the first multicenter randomized controlled trial aiming to assess the role of a bundle of care combining several cardioprotective strategies to reduce myocardial damage in patients undergoing cardiac surgery with cardiopulmonary bypass.

Trial registration

ClinicalTrials.gov, NCT03230136. Registered on July 26, 2017. Last updated on April 17, 2019.
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