Comment on “The direct comparison of inhaled versus intravenous levosimendan in children with pulmonary hypertension undergoing on-cardiopulmonary bypass cardiac surgery: A randomized, controlled, non-inferiority study”

2022 ◽  
Vol 76 ◽  
pp. 110572
Author(s):  
Honggang Zang ◽  
Wenjun Yan ◽  
Wanxia Xie
Keyword(s):  
Pulmonary Hypertension ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Randomized Controlled

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.

A Multicenter, Randomized, Controlled Phase IIb Trial of Avoidance of Hyperoxemia during Cardiopulmonary Bypass

2016 ◽  
Vol 125 (3) ◽  
pp. 465-473 ◽  
Author(s):  
Shay P. McGuinness ◽  
Rachael L. Parke ◽  
Kate Drummond ◽  
Tim Willcox ◽  
Michael Bailey ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Cardiopulmonary Bypass ◽  
Length Of Stay ◽  
Usual Care ◽  
Organ Damage ◽  
Controlled Study ◽  
Multiorgan Dysfunction ◽  
Randomized Controlled

Abstract Background Cardiac surgery utilizing cardiopulmonary bypass (CPB) is one of the most common forms of major surgery. Cardiac surgery–associated multiorgan dysfunction (CSA-MOD) is well recognized and includes acute kidney injury (AKI), hepatic impairment, myocardial damage, and postoperative neurologic deficit. Pathophysiology of CSA-MOD involves numerous injurious pathways linked to the use of CPB including oxidative stress and formation of reactive iron species. During cardiac surgery with CPB, arterial return blood is oxygenated to supranormal levels. This study aimed to determine whether the avoidance of arterial hyperoxemia decreased oxidative stress and reduced the severity of the multiorgan dysfunction in patients undergoing cardiac surgery utilizing CPB. Methods The study was a multicenter, open-label, parallel-group, randomized controlled study of the avoidance of arterial hyperoxemia versus usual care in patients undergoing cardiac surgery involving CPB. Primary outcome was the incidence and severity of AKI. Secondary outcomes included serum biomarkers for CSA-MOD, duration of mechanical ventilation, and length of intensive care and hospital stay. Results A total of 298 patients were randomized and analyzed at two hospitals in New Zealand and Australia. Mean Pao2 was significantly different between groups during CPB. There was no difference in the development of AKI (intervention arm 72.0% vs. usual care 66.2%; difference, −5.8% [95% CI, −16.1 to 4.7%]; P = 0.28), other markers of organ damage, or intensive care unit and hospital length of stay. Conclusions Avoiding modest hyperoxemia during CPB failed to demonstrate any difference in AKI, markers of organ damage, or length of stay.

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 Do continuous forms of intra-operative ultrafiltration enhance recovery after adult cardiac surgery with cardiopulmonary bypass? A protocol for systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Joel Bierer ◽  
David Horne ◽  
Roger Stanzel ◽  
Mark Henderson ◽  
Leah Boulos ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
High Risk ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Inflammatory Syndrome ◽  
Adult Cardiac Surgery

Abstract Background Cardiac surgery with cardiopulmonary bypass (CPB) is associated with a systemic inflammatory syndrome that adversely impacts cardiopulmonary function and can contribute to prolonged postoperative recovery. Intra-operative ultrafiltration during CPB is a strategy developed by pediatric cardiac specialists, aiming to dampen the inflammatory syndrome by removing circulating cytokines and improving coagulation profiles during the cardiac operation. Although ultrafiltration is commonly used in the pediatric population, it is not routinely used in the adult population. This study aims to evaluate if randomized evidence supports the use of continuous intra-operative ultrafiltration to enhance recovery for adults undergoing cardiac surgery with CPB. Methods This systematic review and meta-analysis will include randomized controlled trials (RCT) that feature continuous forms of ultrafiltration during adult cardiac surgery with CPB, specifically assessing for benefit in mortality rates, invasive ventilation time and intensive care unit length of stay (ICU LOS). Relevant RCTs will be retrieved from databases, including MEDLINE, Embase, CENTRAL and Scopus, by a pre-defined search strategy. Search results will be screened for inclusion and exclusion criteria by two independent persons with consensus. Selected RCTs will have study demographics and outcome data extracted by two independent persons and transferred into RevMan. Risk of bias will be independently assessed by the Revised Cochrane Risk-of-Bias (RoB2) tool and studies rated as low-, some-, or high- risk of bias. Meta-analyses will compare the intervention of continuous ultrafiltration against comparators in terms of mortality, ventilation time, ICU LOS, and renal failure. Heterogeneity will be measured by the χ2 test and described by the I2 statistic. A sensitivity analysis will be completed by excluding included studies judged to have a high risk of bias. Summary of findings and certainty of the evidence, determined by the GRADE approach, will display the analysis findings. Discussion The findings of this systematic review and meta-analysis will summarize the evidence to date of continuous forms of ultrafiltration in adult cardiac surgery with CPB, to both inform adult cardiac specialists about this technique and identify critical questions for future research in this subject area. Systematic review registration This systematic review and meta-analysis is registered in PROSPERO CRD42020219309 (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020219309). 

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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