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The risk may increase when NSAIDs are combined with diuretics and angiotensin converting enzyme (ACE) inhibitors or Angiotensin\u2010II\u2010receptor antagonists. The aim of this substudy is to assess potential renal adverse effects of an eight\u2010day postoperative treatment with ibuprofen in patients undergoing hip or knee arthroplasty during 90\u2010days follow\u2010up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and Analysis<\/jats:title>\n                    <jats:p>This substudy is part of the PERISAFE trial\u2014a randomized, placebo\u2010controlled, blinded multicenter trial including 2904 patients undergoing hip or knee arthroplasty. Patients are randomized to receive either ibuprofen 400\u2009mg three times daily or identical placebo three times daily for 8\u2009days postoperatively. The primary outcome is the number of patients with renal dysfunction according to RIFLE criteria Level 1\u20135, at any point during the 90\u2010day follow\u2010up. The substudy is powered at 86.3% to detect or discard a 40% relative risk reduction in the placebo group, assuming an incidence of acute renal injury of 6.2%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and Dissemination<\/jats:title>\n                    <jats:p>The ethical approval for this substudy is included in the main PERISAFE trial, which has been approved by the Danish Medicine Agency, the National Committee on Health Research Ethics (EU CT no. 2022\u2010502502\u201032\u201000), and the Danish Data Protection Agency (REG\u2010149\u20102022).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/aas.70218","type":"journal-article","created":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T05:54:01Z","timestamp":1773381241000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Renal Adverse Events Associated With Ibuprofen Treatment After Hip and Knee Arthroplasties\u2014\n                    <i>A Protocol for the Preplanned Substudy of the PERISAFE Trial<\/i>"],"prefix":"10.1111","volume":"70","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9525-0920","authenticated-orcid":false,"given":"Christina Cleveland Westerdahl","family":"Laursen","sequence":"first","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anesthesiology Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klara N\u00f8rrek\u00e6r","family":"Lund","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anesthesiology Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Troels Haxholdt","family":"Lunn","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care Copenhagen University Hospital  Bispebjerg and Frederiksberg Denmark"},{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8008-6614","authenticated-orcid":false,"given":"Daniel","family":"H\u00e4gi\u2010Pedersen","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"},{"name":"Department of Anesthesiology N\u00e6stved, Slagelse, and Ringsted Hospitals  N\u00e6stved Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne Sofie Nautrup","family":"Therkelsen","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anesthesiology Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathias Therkel","family":"Steensb\u00e6k","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology Copenhagen University Hospital \u2013 North Zealand  Hiller\u00f8d Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit Isberg","family":"Faugstad","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery Aalborg University Hospital  Aalborg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sair","family":"Anjum","sequence":"additional","affiliation":[{"name":"Centre for Anaesthesiological Research, Department of Anesthesiology Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M\u00fcjgan","family":"Yilmaz","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery Nordsj\u00e6llands Hospital  Hiller\u00f8d Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niels Anker","family":"Pedersen","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology N\u00e6stved, Slagelse, and Ringsted Hospitals  N\u00e6stved 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