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


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
19 07 2023
Historique:
medline: 24 7 2023
pubmed: 21 7 2023
entrez: 20 7 2023
Statut: epublish

Résumé

Increased 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 (DAH In 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, DAH This 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). NCT04753307.

Identifiants

pubmed: 37474184
pii: bmjopen-2022-065469
doi: 10.1136/bmjopen-2022-065469
pmc: PMC10357807
doi:

Substances chimiques

Biomarkers 0
Peptide Fragments 0
Natriuretic Peptide, Brain 114471-18-0

Banques de données

ClinicalTrials.gov
['NCT04753307']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e065469

Investigateurs

Alexander Pichler (A)
Christian Reiterer (C)
Michael Eichlseder (M)
Alexandra Graf (A)
Michael Eichinger (M)
Barbara Kabon (B)
Nicole Hantakova (N)
Simon Schallmeiner (S)
Melanie Kuhrn (M)
Andrea Kurz (A)
Alexander Taschner (A)
Daniel Freidorfer (D)
David West (D)
Andreas Heri (A)
Stefan Trinkl (S)
Tobias Marr (T)
Melanie Fraunschiel (M)
Victor Xu (V)
Andreas Bayer (A)
Asmir Osmanovic (A)
Tobias Niedrist (T)
Edith Fleischmann (E)
Nikolas Adamowitsch (N)
Katharina Horvath (K)
Moritz Morgenroth (M)
Georg Vitousek (G)
Hani Essber (H)

Informations de copyright

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Alexander Pichler (A)

Division of Anaesthesiology and Intensive Care Medicine 1, Medical University of Graz, Graz, Austria.
Outcome Research Consortium, Cleveland, Ohio, USA.

Andrea Kurz (A)

Division of Anaesthesiology and Intensive Care Medicine 1, Medical University of Graz, Graz, Austria ak@or.org.
Outcome Research Consortium, Cleveland, Ohio, USA.

Michael Eichlseder (M)

Division of Anaesthesiology and Intensive Care Medicine 1, Medical University of Graz, Graz, Austria.
Outcome Research Consortium, Cleveland, Ohio, USA.

Alexandra Graf (A)

Center for Medical Data Science, Medical University of Vienna, Vienna, Austria.

Michael Eichinger (M)

Division of Anaesthesiology and Intensive Care Medicine 1, Medical University of Graz, Graz, Austria.
Outcome Research Consortium, Cleveland, Ohio, USA.

Alexander Taschner (A)

Outcome Research Consortium, Cleveland, Ohio, USA.
Department of Anaesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.

Barbara Kabon (B)

Outcome Research Consortium, Cleveland, Ohio, USA.
Department of Anaesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.

Edith Fleischmann (E)

Outcome Research Consortium, Cleveland, Ohio, USA.
Department of Anaesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.

Christian Reiterer (C)

Outcome Research Consortium, Cleveland, Ohio, USA.
Department of Anaesthesia, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.

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