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

ABSTRACT

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION ClinicalTrials.gov, ID NCT03366857. Registered on 8th December 2017.