PerIoperative iNflammatory reSponse assessment In hiGH-risk patienTs undergoing non-cardiac surgery (INSIGHT): study protocol of a prospective non-interventional observational study

• Published in: BMJ open Vol. 13; no. 7; p. e065469
• Main Authors: Pichler, Alexander, Kurz, Andrea, Eichlseder, Michael, Graf, Alexandra, Eichinger, Michael, Taschner, Alexander, Kabon, Barbara, Fleischmann, Edith, Reiterer, Christian, Hantakova, Nicole, Schallmeiner, Simon, Kuhrn, Melanie, Freidorfer, Daniel, West, David, Heri, Andreas, Trinkl, Stefan, Marr, Tobias, Fraunschiel, Melanie, Xu, Victor, Bayer, Andreas, Osmanovic, Asmir, Niedrist, Tobias, Adamowitsch, Nikolas, Horvath, Katharina, Morgenroth, Moritz, Vitousek, Georg, Essber, Hani
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 19.07.2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Adult anaesthesia; Anaesthesia; Biomarkers; Cardiac arrhythmia; Cardiovascular disease; Coronary vessels; Cytokines; Heart attacks; Heart Diseases - etiology; Heart failure; Humans; Inflammation; Inflammation - complications; Informed consent; Ischaemic heart disease; Kidneys; Multicenter Studies as Topic; Natriuretic Peptide, Brain; Observational studies; Observational Studies as Topic; Patients; Peptide Fragments; Peptides; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Predictive Value of Tests; Prospective Studies; Proteins; Risk Assessment; Stroke; SURGERY; Transient ischemic attack; Vein & artery diseases; Canada; Montreal Quebec Canada; SURGERY; Ischaemic heart disease; Adult anaesthesia
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-065469

IntroductionIncreased inflammatory processes after non-cardiac surgery are very common. The association between postoperative inflammation and the occurrence of cardiovascular complications after non-cardiac surgery are still not entirely clear. Therefore, we will evaluate the association between postoperative inflammation and the occurrence of major cardiovascular complications in patients at-risk for cardiovascular complications undergoing non-cardiac surgery. We will further evaluate the association of postoperative inflammation and days-at-home within 30 days after surgery (DAH30), the incidence of acute kidney injury, postoperative N-terminal probrain natriuretic peptide (NT-proBNP) concentrations and neurocognitive decline.Methods and analysisIn this multicentre study, we will include 1400 patients at-risk for cardiovascular complications undergoing non-cardiac surgery. Our primary aim is to evaluate the association of postoperative maximum C-reactive protein concentration and the occurrence of a composite of five major cardiovascular complications (myocardial infarction, myocardial injury after non-cardiac surgery, new onset of atrial fibrillation, stroke and death) within 30 days after surgery using a Mann-Whitney-U test as well as a logistic regression model. As our secondary aim, we will evaluate the association of a composite of three inflammatory biomarkers (interleukin 6, procalcitonin and copeptin) on the occurrence of our composite of five cardiovascular complications within 30 days and 1 year after surgery, acute kidney injury, DAH30 and NT-proBNP concentrations using linear or logistic regression models. We will measure inflammatory biomarkers before surgery, and on the first, second, third and fifth postoperative day. We will check medical records and conduct a telephone survey 30 days and 1 year after surgery. We evaluate neurocognitive function, using a Montreal Cognitive Assessment, before and 1 year after surgery.Ethics and disseminationThis study was approved by the ethics committees at the Medical University of Vienna (2458/2020) and at the Medical University of Graz (33-274 ex 20/21).Trial registration numberNCT04753307.