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

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Pascal Chiari ◽  
Michel Durand ◽  
Olivier Desebbe ◽  
Marc-Olivier Fischer ◽  
Diane Lena-Quintard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Blood Glucose ◽  
Cardiopulmonary Bypass ◽  
Insulin Infusion ◽  
Controlled Trial ◽  
Myocardial Damage ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Glucose Management

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.

scholarly journals Multimodal cardio protective strategy in cardiac surgery (The PROCCARD trial): Study protocol for a multicenter randomized controlled trial

2019 ◽  
Author(s):  
Pascal Chiari ◽  
Michel Durand ◽  
Olivier Desebbe ◽  
Marc-Olivier Fischer ◽  
Diane Lena-Quintard ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Blood Glucose ◽  
Cardiopulmonary Bypass ◽  
Insulin Infusion ◽  
Controlled Trial ◽  
Myocardial Damage ◽  
Treated Group ◽  
Multicenter Randomized Controlled Trial ◽  
Protective Strategies ◽  
Glucose Management

Abstract Background Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing either with preconditioning or postconditioning or assessing a single aspect of cardioprotection showed 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. 210 patients scheduled for aortic valve surgery with or without coronary artery bypass grafting will be assigned to a control or a treated 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 treated 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 the myocardial damage measured by postoperative 72-h area under the curve of high-sensitive 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 cardio protective strategies to reduce myocardial damage in patients undergoing cardiac surgery with cardiopulmonary bypass.

scholarly journals Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Thiago Augusto Azevedo Maranhão Cardoso ◽  
Gudrun Kunst ◽  
Caetano Nigro Neto ◽  
José de Ribamar Costa Júnior ◽  
Carlos Gustavo Santos Silva ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Inflammatory Response ◽  
Controlled Trial ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Volatile Anesthetic ◽  
Serum Levels ◽  
Randomized Controlled

Abstract Background Recent experimental evidence shows that sevoflurane can reduce the inflammatory response during cardiac surgery with cardiopulmonary bypass. However, this observation so far has not been assessed in an adequately powered randomized controlled trial. Methods We plan to include one hundred patients undergoing elective coronary artery bypass graft with cardiopulmonary bypass who will be randomized to receive either volatile anesthetics during cardiopulmonary bypass or total intravenous anesthesia. The primary endpoint of the study is to assess the inflammatory response during cardiopulmonary bypass by measuring PMN-elastase serum levels. Secondary endpoints include serum levels of other pro-inflammatory markers (IL-1β, IL-6, IL-8, TNFα), anti-inflammatory cytokines (TGFβ and IL-10), and microRNA expression in peripheral blood to achieve possible epigenetic mechanisms in this process. In addition clinical endpoints such as presence of major complications in the postoperative period and length of hospital and intensive care unit stay will be assessed. Discussion The trial may determine whether adding volatile anesthetic during cardiopulmonary bypass will attenuate the inflammatory response. Trial registration ClinicalTrials.gov NCT02672345. Registered on February 2016 and updated on June 2020.

scholarly journals Randomized, Controlled Trial of Individualized Heparin and Protamine Management in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass

2010 ◽  
Vol 56 (22) ◽  
pp. 1794-1802 ◽  
Author(s):  
Colleen E. Gruenwald ◽  
Cedric Manlhiot ◽  
Anthony K. Chan ◽  
Lynn Crawford-Lean ◽  
Celeste Foreman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): A protocol for a randomized, controlled trial

2019 ◽  
Author(s):  
Brian O'Gara ◽  
Balachundhar Subramaniam ◽  
Shahzad Shaefi ◽  
Ariel Mueller ◽  
Valerie Banner-Goodspeed ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Lung Injury ◽  
Ischemia Reperfusion ◽  
Controlled Trial ◽  
Pulmonary Inflammation ◽  
Pulmonary Complications ◽  
Postoperative Pulmonary Complications ◽  
Randomized Controlled

Abstract Background Patients undergoing cardiac surgery with cardiopulmonary bypass are at an increased risk of developing postoperative pulmonary complications, potentially leading to excess morbidity and mortality. It is likely that pulmonary ischemia-reperfusion (IR) injury during cardiopulmonary bypass is a major contributor to perioperative lung injury. Therefore, interventions that can minimize IR injury would be valuable in reducing the excess burden of this potentially preventable disease process. Volatile anesthetics including sevoflurane have been shown in both preclinical and human trials to effectively limit pulmonary inflammation in a number of settings including ischemia-reperfusion injury. However, this finding has not yet been demonstrated in the cardiac surgery population. The Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS) trial is a randomized, controlled trial investigating whether sevoflurane anesthetic maintenance can modulate pulmonary inflammation occurring during cardiac surgery with cardiopulmonary bypass, and whether this potential effect can translate to a reduction in postoperative pulmonary complications. Methods APLICS is a prospective, randomized controlled trial of adult cardiac surgical patients. Subjects will be randomized to receive intraoperative anesthetic maintenance with either sevoflurane or propofol. Patients in both groups will be ventilated according to protocols intended to minimize the influences of ventilator induced lung injury and hyperoxia. Bronchoalveolar lavage (BAL) and blood sampling will take place after anesthetic induction and between two to four hours after pulmonary reperfusion. The primary outcome is a difference between groups in the degree of post-bypass lung inflammation, defined by BAL concentrations of TNFa. Secondary outcomes will include differences in additional relevant BAL and systemic inflammatory markers and the incidence of postoperative pulmonary complications. Discussion APLICS investigates whether anesthetic choice can influence lung inflammation and pulmonary outcomes following cardiac surgery with cardiopulmonary bypass. A positive result from this trial would add to the growing body of evidence describing the lung protective properties of the volatile anesthetics and potentially reduce unnecessary morbidity for cardiac surgery patients. Trial Registration ClinicalTrials.gov identifier NCT02918877, registered on September 29, 2016.

scholarly journals Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): A protocol for a randomized, controlled trial

2019 ◽  
Author(s):  
Brian P. O’Gara ◽  
Balachundhar Subramaniam ◽  
Shahzad Shaefi ◽  
Ariel Mueller ◽  
Valerie Banner-Goodspeed ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Lung Injury ◽  
Ischemia Reperfusion ◽  
Controlled Trial ◽  
Pulmonary Inflammation ◽  
Pulmonary Complications ◽  
Postoperative Pulmonary Complications ◽  
Randomized Controlled

Abstract Background Patients undergoing cardiac surgery with cardiopulmonary bypass are at an increased risk of developing postoperative pulmonary complications, potentially leading to excess morbidity and mortality. It is likely that pulmonary ischemia-reperfusion (IR) injury during cardiopulmonary bypass is a major contributor to perioperative lung injury. Therefore, interventions that can minimize IR injury would be valuable in reducing the excess burden of this potentially preventable disease process. Volatile anesthetics including sevoflurane have been shown in both preclinical and human trials to effectively limit pulmonary inflammation in a number of settings including ischemia-reperfusion injury. However, this finding has not yet been demonstrated in the cardiac surgery population. The Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS) trial is a randomized, controlled trial investigating whether sevoflurane anesthetic maintenance can modulate pulmonary inflammation occurring during cardiac surgery with cardiopulmonary bypass, and whether this potential effect can translate to a reduction in postoperative pulmonary complications. Methods APLICS is a prospective, randomized controlled trial of adult cardiac surgical patients. Subjects will be randomized to receive intraoperative anesthetic maintenance with either sevoflurane or propofol. Patients in both groups will be ventilated according to protocols intended to minimize the influences of ventilator induced lung injury and hyperoxia. Bronchoalveolar lavage (BAL) and blood sampling will take place after anesthetic induction and between two to four hours after pulmonary reperfusion. The primary outcome is a difference between groups in the degree of post-bypass lung inflammation, defined by BAL concentrations of TNFa. Secondary outcomes will include differences in additional relevant BAL and systemic inflammatory markers and the incidence of postoperative pulmonary complications. Discussion APLICS investigates whether anesthetic choice can influence lung inflammation and pulmonary outcomes following cardiac surgery with cardiopulmonary bypass. A positive result from this trial would add to the growing body of evidence describing the lung protective properties of the volatile anesthetics and potentially reduce unnecessary morbidity for cardiac surgery patients. Trial Registration ClinicalTrials.gov identifier NCT02918877, registered on September 29, 2016.

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