Evidence map›Paper›PMID 31511041›Full record

ArticleTrials2019

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

Pascal Chiari, Michel Durand, Olivier Desebbe, Marc-Olivier Fischer, Diane Lena-Quintard, Jean-Charles Palao, Catherine Mercier, Géraldine Samson, Yvonne Varillon, Matteo Pozzi and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03230136 (Protection During Cardiac Surgery.), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03230136 nacompletednot on this map

Protection During Cardiac Surgery.

TypeinterventionalSponsorHospices Civils de LyonRan2018 to 2019Enrolled210ConditionsThoracic Surgery, Cardiopulmonary BypassArmsmultimodal cardioprotection strategy, standard anesthetic procedure
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Do we correctly calculate doses of cardioplegia during aortic valve replacement procedures? A preliminary report.Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery · 2023
    Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Pascal ChiariService d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, F-69677, Lyon, France. pascal.chiari@chu-lyon.fr.
Michel DurandPole d'Anesthésie-Réanimation, Hôpital Albert Michallon, Centre Hospitalier Universitaire de Grenoble-Alpes, F-38043, Grenoble, France.
Olivier DesebbeService d'Anesthésie-Réanimation, Clinique de la Sauvegarde, Ramsay Générale de Santé, F-69009, Lyon, France.
Marc-Olivier FischerService d'Anesthésie-Réanimation, Centre Hospitalier Universitaire de Caen, F-14033, Caen, France.
Diane Lena-QuintardService d'Anesthésie-Réanimation, Institut Arnault Tzanck, F-06721, Saint Laurent du Var, France.
Jean-Charles PalaoService d'Anesthésie-Réanimation, Hôpital Nord, Centre Hospitalier Universitaire de Saint Etienne, F-42277, Saint Etienne, France.
Catherine MercierService de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, F-69003, Lyon, France.
Géraldine SamsonCentre d'Investigation Clinique de Lyon (CIC 1407 Inserm), Hospices Civils de Lyon, F-69677, Lyon, France.
Yvonne VarillonCentre d'Investigation Clinique de Lyon (CIC 1407 Inserm), Hospices Civils de Lyon, F-69677, Lyon, France.
Matteo PozziService de Chirurgie Cardiaque, Hôpital Louis Pradel, Hospices Civils de Lyon, F-69677, Lyon, France.
Nathan MewtonInserm U1060, Laboratoire CarMeN, IHU OPeRa, F-69394, Lyon, France.
Delphine Maucort-BoulchService de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, F-69003, Lyon, France.
Michel OvizeInserm U1060, Laboratoire CarMeN, IHU OPeRa, F-69394, Lyon, France.
Jean-Luc FellahiService d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, F-69677, Lyon, France.

Funding

Ministère des Affaires Sociales et de la Santé PHRCI-16-004
6 · The paper itself

Abstract

backgroundMyocardial 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.

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

Indexed as

Aortic ValveCoronary Artery BypassBlood GlucoseCardiopulmonary BypassHumansIschemic PreconditioningMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesResearch DesignSingle-Blind MethodBlood GlucoseCardiac surgeryCardioprotectionCardiopulmonary bypassMultimodal strategyPostconditioningPreconditioning

Identifiers

PMID31511041
PMCPMC6737694

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.