Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial
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...
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| Format: | Article |
| Language: | English |
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BMC
2019-09-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3638-3 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Pascal Chiari |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-23T06:41:32Z |
| format | Article |
| id | doaj.art-f03257fef9324a76b5f6d783209b8d7a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-23T06:41:32Z |
| publishDate | 2019-09-01 |
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| record_format | Article |
| series | Trials |
| spelling | doaj.art-f03257fef9324a76b5f6d783209b8d7a2022-12-21T17:56:41ZengBMCTrials1745-62152019-09-012011910.1186/s13063-019-3638-3Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trialPascal Chiari0Michel Durand1Olivier Desebbe2Marc-Olivier Fischer3Diane Lena-Quintard4Jean-Charles Palao5Catherine Mercier6Géraldine Samson7Yvonne Varillon8Matteo Pozzi9Nathan Mewton10Delphine Maucort-Boulch11Michel Ovize12Jean-Luc Fellahi13Service d’Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de LyonPole d’Anesthésie-Réanimation, Hôpital Albert Michallon, Centre Hospitalier Universitaire de Grenoble-AlpesService d’Anesthésie-Réanimation, Clinique de la Sauvegarde, Ramsay Générale de SantéService d’Anesthésie-Réanimation, Centre Hospitalier Universitaire de CaenService d’Anesthésie-Réanimation, Institut Arnault TzanckService d’Anesthésie-Réanimation, Hôpital Nord, Centre Hospitalier Universitaire de Saint EtienneService de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de LyonCentre d’Investigation Clinique de Lyon (CIC 1407 Inserm), Hospices Civils de LyonCentre d’Investigation Clinique de Lyon (CIC 1407 Inserm), Hospices Civils de LyonService de Chirurgie Cardiaque, Hôpital Louis Pradel, Hospices Civils de LyonInserm U1060, Laboratoire CarMeN, IHU OPeRaService de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de LyonInserm U1060, Laboratoire CarMeN, IHU OPeRaService d’Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de LyonAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3638-3CardioprotectionCardiac surgeryCardiopulmonary bypassPreconditioningPostconditioningMultimodal strategy |
| spellingShingle | 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 Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial Trials Cardioprotection Cardiac surgery Cardiopulmonary bypass Preconditioning Postconditioning Multimodal strategy |
| title | Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial |
| title_full | Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial |
| title_fullStr | Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial |
| title_full_unstemmed | Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial |
| title_short | Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial |
| title_sort | multimodal cardioprotective strategy in cardiac surgery the proccard trial study protocol for a multicenter randomized controlled trial |
| topic | Cardioprotection Cardiac surgery Cardiopulmonary bypass Preconditioning Postconditioning Multimodal strategy |
| url | http://link.springer.com/article/10.1186/s13063-019-3638-3 |
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