Abstract 14827: Nitric Oxide During Cardiopulmonary Bypass Improves Clinical Outcome: A Blinded, Randomized Controlled Trial

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Christopher S James ◽  
Stephen Horton ◽  
Christian Brizard ◽  
Charlotte Molesworth ◽  
Johnny Millar ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Length Of Stay ◽  
Gas Flow ◽  
Controlled Trial ◽  
Age Group ◽  
Randomized Controlled ◽  
Icu Length Of Stay

Background: Children requiring cardiac surgery with cardiopulmonary bypass (CPB) frequently develop Low Cardiac Output Syndrome (LCOS), particularly when very young, A pilot study of 16 children by Checchia et al. (2013) showed that the delivery of nitric oxide (NO) to the CPB circuit shortened duration of mechanical ventilation and ICU stay. We hypothesized that administering NO to oxygenator gas flow during CPB would decrease the incidence of LCOS and effect subsequent clinical outcomes. Methods: We conducted a prospective, blinded, randomized controlled trial in children with congenital heart disease having surgery with CPB. Randomization was stratified by age and ‘blocked’ at six in each group. Children received oxygen alone or 20 ppm gaseous NO and oxygen to the CPB gas administration line. Only the study perfusionist was aware of the allocation and all equipment and devices were otherwise identical in each group; in particular the cardiac surgeon and anesthetist remained blinded to patient allocation. Results: 198 children were enrolled following written consent. There were no differences in patient characteristics, diagnoses or surgeries between groups. 101 children received NO and had a significant reduction in LCOS (14% vs 31%, p=0.004), use of ECMO (1% vs 8%, p=0.014) and a non-significant reduction in ICU length of stay (48hrs vs 72hrs, p=0.111), compared to the 97 children who did not receive NO. The reduction in LCOS was most pronounced in children less than 6 weeks of age (20% vs 52%, p=0.012) and in those aged 6 weeks to 2 years (6% vs 24%, p=0.026), who also had significantly reduced ICU length of stay (43hrs vs 84hrs, p=0.031). LCOS occurred equally between groups in children greater than 2 years of age (17% vs 21%, p=0.678). There was no difference in the amount of post-operative bleeding in any age group. Children greater than 2 years of age who received NO required fewer blood transfusions (8.3% vs 24.1%, p=0.096). Conclusions: Delivery of NO to the CPB circuit for children undergoing cardiac surgery significantly reduces the incidence of LCOS, use of ECMO and ICU length of stay by varying degrees, according to age group.

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.

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

2018 ◽  
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 ◽  
Volatile Anesthetics ◽  
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 incidence of inflammatory lung injury, defined by an increase in post-bypass BAL concentrations of TNFα. Secondary outcomes will include 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. KEYWORDS Inflammatory lung injury, volatile anesthetics, cardiac surgery, postoperative pulmonary complications, TNFα.

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