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

• Published in: Current controlled trials in cardiovascular medicine 2020-05, Vol.21 (1), p.400-9, Article 400
• Main Authors: Reiterer, Christian, Kabon, Barbara, von Sonnenburg, Markus Falkner, Starlinger, Patrick, Taschner, Alexander, Zotti, Oliver, Goshin, Julius, Drlicek, Gregor, Fleischmann, Edith
• Format: Article
• Language: English
• Subjects: Abdomen - surgery; Abdominal surgery; Age; Aged; Anesthesia; Austria - epidemiology; Blood pressure; Cardiac patients; Cardiovascular disease; Cardiovascular system; Clinical trials; Diabetes; Double-Blind Method; Electrocardiography; Female; Fluid Therapy - methods; Fluid Therapy - statistics & numerical data; Heart attacks; Heart Diseases - complications; Heart Diseases - physiopathology; Heart failure; Heart Function Tests - methods; Hemodynamics; Humans; Hypotheses; Insulin; Intensive care; Intubation; Male; Medical schools; Middle Aged; Natriuretic Peptide, Brain - blood; Natriuretic Peptide, Brain - metabolism; Natriuretic peptides; Oxidation-Reduction; Oxygen - adverse effects; Oxygen - supply & distribution; Peptide Fragments - blood; Peptides; Perioperative Period; Postoperative Period; Predictive Value of Tests; Prospective Studies; Risk Assessment; Risk Factors; Study Protocol; Sympathetic Nervous System - metabolism; Sympathetic Nervous System - physiopathology; Troponin; Troponin T - metabolism; Von Willebrand factor; von Willebrand Factor - metabolism
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-020-04336-9

Elevated postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery. Studies indicate that supplemental oxygen decreases sympathetic nerve activity and might, therefore, improve cardiovascular function. Thus, we will test the effect of perioperative supplemental oxygen administration on NT-proBNP release after surgery. We will conduct a single-center, double-blinded, randomized trial at the Medical University of Vienna, including 260 patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery. Patients will be randomly assigned to receive 80% versus 30% oxygen during surgery and for 2 h postoperatively. The primary outcome will be the difference in maximum NT-proBNP release after surgery. As secondary outcomes we will assess the effect of supplemental oxygen on postoperative maximum troponin T concentration, oxidation-reduction potential, von Willebrand factor concentration and perioperative fluid requirements. We will perform outcome measurements 2 h after surgery, on postoperative day 1 and on postoperative day 3. The NT-proBNP concentration and the oxidation-reduction potential will also be measured within 72 h before discharge. Our trial should determine whether perioperative supplemental oxygen administration will reduce the postoperative release of NT-proBNP in patients with preoperative increased cardiovascular risk factors undergoing noncardiac surgery. ClinicalTrials.gov, ID: NCT03366857. Registered on 8th December 2017.