The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients – a protocol for a prosprective randomized clinical trial

Reiterer, Christian; Kabon, Barbara; Sonnenburg, Markus Falkner von; Starlinger, Patrick; Taschner, Alexander; Zotti, Oliver; Goshin, Julius; Drlicek, Gregor; Fleischmann, Edith

doi:10.1186/s13063-020-04336-9

Cited by 10 publications

(15 citation statements)

References 32 publications

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“…The trial was approved by the local Institutional Review Board and was registered at ClinicalTrials.gov (NCT 03366857) and at the European Clinical Trial Database (EudraCT 2017-003714-68). The study protocol was published previously [ 11 ]. In our main trial, we did not observe a significant difference in maximum postoperative NT-proBNP concentrations between patients receiving 80% and 30% oxygen for the duration of surgery and the first two postoperative hours [ 10 ].…”

Section: Methodsmentioning

confidence: 99%

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Perioperative Supplemental Oxygen and Plasma Catecholamine Concentrations after Major Abdominal Surgery—Secondary Analysis of a Randomized Clinical Trial

Taschner

Kabon

Sonnenburg

et al. 2022

JCM

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Perioperative stress is associated with increased sympathetic activity that leads to increases in heart rate and blood pressure, which are associated with the development of perioperative myocardial ischemia. In healthy volunteers, it was shown that the administration of supplemental oxygen attenuated sympathetic nerve activity and subsequently led to lower plasma catecholamine concentrations. We therefore tested the hypothesis that perioperative supplemental oxygen attenuates sympathetic nerve in patients at risk for cardiovascular complications undergoing major abdominal surgery. We randomly assigned 81 patients to receive either 80% or 30% inspired oxygen concentration throughout surgery and the first two postoperative hours. We assessed noradrenaline, adrenaline, and dopamine plasma concentrations before the induction of anesthesia, two hours after surgery and on the third postoperative day. There was no significant difference in postoperative noradrenaline (effect estimated: −41.5 ng·L−1, 95%CI −134.3, 51.2; p = 0.38), adrenaline (effect estimated: 11.2 ng·L−1, 95%CI −7.6, 30.1; p = 0.24), and dopamine (effect estimated: −1.61 ng·L−1, 95%CI −7.2, 3.9; p = 0.57) concentrations between both groups. Based on our results, it seems unlikely that supplemental oxygen influences endogenous catecholamine release in the perioperative setting.

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Section: Methodsmentioning

confidence: 99%

“…Patients in the 30% oxygen group received an inspired oxygen fraction of 0.3 throughout surgery and 3 L/min oxygen via facemask without a reservoir for the first two postoperative hours. If needed, oxygen fraction was increased at the discretion of the attending anesthetist according to a predefined algorithm [ 11 ].…”

Section: Methodsmentioning

confidence: 99%

Perioperative Supplemental Oxygen and Plasma Catecholamine Concentrations after Major Abdominal Surgery—Secondary Analysis of a Randomized Clinical Trial

Taschner

Kabon

Sonnenburg

et al. 2022

JCM

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“…The study protocol was published previously. 13 We obtained written informed consent from all patients before randomization. We included 82 consecutive patients enrolled into the main study and scheduled for major abdominal surgery expected to last at least 2 hours.…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…If needed, oxygen fraction was increased at the discretion of the attending anesthetist according to a prede ned algorithm. 13…”

Section: Randomizationmentioning

confidence: 99%

Perioperative Supplemental Oxygen and Plasma Catecholamine Concentrations After Major Abdominal Surgery – a Substudy of a Randomized Clinical Trial

Taschner

Kabon

Sonnenburg

et al. 2021

Preprint

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BackgroundIncreased sympathetic nerve activity due to perioperative stress is associated with higher plasma catecholamine concentrations that lead to an increase in heart rate and blood pressure. This fact plays a pivotal role in the development of perioperative myocardial ischemia. A previous study in healthy volunteers has shown that the administration of supplemental oxygen attenuated sympathetic nerve activity, which was associated with lower plasma catecholamine concentrations. However, in patients undergoing surgery evidence is still lacking. We therefore tested the hypothesis that perioperative supplemental oxygen attenuates sympathetic nerve activity estimated by plasma catecholamines in patients at risk for cardiovascular complications undergoing major abdominal surgery.MethodsWe randomly assigned 81 patients to receive either 80% versus 30% inspired oxygen concentration throughout surgery and for the first two postoperative hours. We assessed noradrenaline, adrenaline and dopamine plasma concentrations as surrogate parameters for sympathetic nerve activity before induction of anesthesia, two hours after surgery and on the third postoperative day.Results41 patients received 80% oxygen and 40 patients received 30% oxygen. There was no significant difference in postoperative noradrenaline (effect estimated:-41.5 ng.L-1, 95%CI -134.3, 51.2; p=0.38), adrenaline (effect estimated:11.2 ng.L-1, 95%CI -7.6, 30.1; p=0.24) and dopamine (effect estimated:-1.61 ng.L-1, 95%CI -7.2, 3.9; p=0.57) concentrations between both groups. ConclusionsWe found no significant difference in postoperative plasma catecholamine concentration between the 80% and 30% oxygen group in patients at risk for cardiovascular complications undergoing major abdominal surgery. Based on our results, it seems likely that supplemental oxygen did not influence sympathetic nerve activity in the perioperative setting.Trial RegistrationClinicalTrials.gov (NCT 03366857)European Clinical Trial Database (EudraCT 2017-003714-68)

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“…In detail, a meta-analysis of 2179 patients has shown that postoperative BNP values over 92 ng/L or NT-pro-BNP over 300 ng/L were the strongest independent predictors of 30-day mortality and non-fatal myocardial infarction (MI) in patients undergoing non-cardiac surgery 1. We have previously shown that NT-pro-BNP concentrations increases significantly within the first three postoperative days in relatively healthy patients as well as in patients with cardiovascular risk factors undergoing moderate- to high-risk abdominal surgery, which we assumed reflect increased myocardial strain in the postoperative period 6 7…”

Section: Introductionmentioning

confidence: 99%

Effect of perioperative levosimendan administration on postoperative N-terminal pro-B-type natriuretic peptide concentration in patients with increased cardiovascular risk factors undergoing non-cardiac surgery: protocol for the double-blind, randomised, placebo-controlled IMPROVE trial

et al. 2022

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IntroductionElevated N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after non-cardiac surgery is a strong predictor for cardiovascular complications and reflects increased myocardial strain. NT-pro-BNP concentrations significantly rise after non-cardiac surgery within the first 3 days. Levosimendan is a potent inotropic drug that increases calcium sensitivity to cardiac myocytes, which results in improved cardiac contractility that last for approximately 7 days. Thus, we will test the effect of a pre-emptive perioperative administration of levosimendan on postoperative NT-pro-BNP concentration as compared with the administration of a placebo in patients undergoing moderate-risk to high-risk major abdominal surgery.Methods and analysisWe will conduct a double-blinded prospective randomised trial at the Medical University of Vienna, Vienna, Austria (and potentially a second centre in Germany), including 230 patients at-risk for cardiovascular complications undergoing moderate- to high-risk major abdominal surgery. Patients will be randomly assigned to receive a single dose of 12.5 mg levosimendan versus placebo after induction of anaesthesia. The primary outcome will be the postoperative maximum NT-pro-BNP concentration between both group within the first three postoperative days. Our secondary outcomes will be the incidence of myocardial ischaemia, myocardial injury after non-cardiac surgery and a composite of myocardial infarction and death within 30 days and 1 year after surgery between both groups. Our further secondary outcome will be stratification of NT-pro-BNP values according to previously thresholds to predict mortality of myocardial infarction after surgery.Ethics and disseminationThe study was approved by the Ethics Committee of the Medical University of Vienna on 14 July 2020 (EK 2187/2019). Written informed consent will be obtained from all patients a day before surgery. Results of this study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04329624.

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The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients – a protocol for a prosprective randomized clinical trial

Cited by 10 publications

References 32 publications

Perioperative Supplemental Oxygen and Plasma Catecholamine Concentrations after Major Abdominal Surgery—Secondary Analysis of a Randomized Clinical Trial

Perioperative Supplemental Oxygen and Plasma Catecholamine Concentrations after Major Abdominal Surgery—Secondary Analysis of a Randomized Clinical Trial

Perioperative Supplemental Oxygen and Plasma Catecholamine Concentrations After Major Abdominal Surgery – a Substudy of a Randomized Clinical Trial

Effect of perioperative levosimendan administration on postoperative N-terminal pro-B-type natriuretic peptide concentration in patients with increased cardiovascular risk factors undergoing non-cardiac surgery: protocol for the double-blind, randomised, placebo-controlled IMPROVE trial

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