title: Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial.
abstract: BACKGROUND
  Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump. At the time of surgery, compared with placebo, methylprednisolone divided into two intravenous doses of 250 mg each may reduce the risk of postoperative acute kidney injury (AKI).
  
  
  METHODS
  With respect to the study schedule, over 7000 substudy eligible patients from 81 centres in 18 countries were randomised in December 2013. The authors will use a logistic regression to estimate the adjusted OR of methylprednisolone versus placebo on the primary outcome of AKI in the 14 days following surgery (a postoperative increase in serum creatinine of ≥50%, or ≥26.5 μmol/L, from the preoperative value). The stage of AKI will also be considered, as will the outcome of AKI in those with and without preoperative chronic kidney disease. After receipt of grant funding, the authors began to record additional perioperative serum creatinine measurements in consecutive patients enrolled at substudy participating centres, and patients were invited to enroll in a 6-month serum creatinine collection. In these trial subpopulations, the authors will consider the outcome of AKI defined in alternate ways, and the outcome of a 6-month change in kidney function from the preoperative value.
  
  
  BACKGROUND
  The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this SIRS AKI substudy. Ethics approval was obtained for additional serum creatinine recordings in consecutive patients enrolled at participating centres. The additional kidney data collection first began for patients enrolled after 1 March 2012. In patients who provided consent, the last 6-month kidney outcome data will be collected in 2014. The results will be reported no later than 2015.
  
  
  BACKGROUND
  Number NCT00427388.
authors.affiliation: Western University, London, Canada.
authors.forename: Amit X
authors.initials: AX
authors.lastname: Garg
authors.forename: Jessica
authors.initials: J
authors.lastname: Vincent
authors.forename: Meaghan
authors.initials: M
authors.lastname: Cuerden
authors.forename: Chirag
authors.initials: C
authors.lastname: Parikh
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
authors.forename: Kevin
authors.initials: K
authors.lastname: Teoh
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.forename: Ainslie
authors.initials: A
authors.lastname: Hildebrand
authors.forename: Andre
authors.initials: A
authors.lastname: Lamy
authors.forename: Yunxia
authors.initials: Y
authors.lastname: Zuo
authors.forename: Daniel I
authors.initials: DI
authors.lastname: Sessler
authors.forename: Pallav
authors.initials: P
authors.lastname: Shah
authors.forename: Seyed Hesameddin
authors.initials: SH
authors.lastname: Abbasi
authors.forename: Mackenzie
authors.initials: M
authors.lastname: Quantz
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Yared
authors.forename: Nicolas
authors.initials: N
authors.lastname: Noiseux
authors.forename: Georgios
authors.initials: G
authors.lastname: Tagarakis
authors.forename: Antoine
authors.initials: A
authors.lastname: Rochon
authors.forename: Janice
authors.initials: J
authors.lastname: Pogue
authors.forename: Michael
authors.initials: M
authors.lastname: Walsh
authors.forename: Matthew T V
authors.initials: MT
authors.lastname: Chan
authors.forename: Francois
authors.initials: F
authors.lastname: Lamontagne
authors.forename: Abbas
authors.initials: A
authors.lastname: Salehiomran
authors.forename: Richard
authors.initials: R
authors.lastname: Whitlock
mesh_terms: D058186:Acute Kidney Injury / Q000517:prevention & control*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002170:Canada; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D002985:Clinical Protocols; D003404:Creatinine / Q000097:blood; D006801:Humans; D008775:Methylprednisolone / Q000627:therapeutic use*; D012107:Research Design; D012307:Risk Factors
chemical_list: D000893:Anti-Inflammatory Agents; D015415:Biomarkers; D003404:Creatinine; D008775:Methylprednisolone