title: Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial.
abstract: BACKGROUND
  Perioperative Ischaemic Evaluation-2 (POISE-2) is an international 2×2 factorial randomised controlled trial of low-dose aspirin versus placebo and low-dose clonidine versus placebo in patients who undergo non-cardiac surgery. Perioperative aspirin (and possibly clonidine) may reduce the risk of postoperative acute kidney injury (AKI).
  
  
  METHODS
  After receipt of grant funding, serial postoperative serum creatinine measurements began to be recorded in consecutive patients enrolled at substudy participating centres. With respect to the study schedule, the last of over 6500 substudy patients from 82 centres in 21 countries were randomised in December 2013. The authors will use logistic regression to estimate the adjusted OR of AKI following surgery (compared with the preoperative serum creatinine value, a postoperative increase ≥26.5 μmol/L in the 2 days following surgery or an increase of ≥50% in the 7 days following surgery) comparing each intervention to placebo, and will report the adjusted relative risk reduction. Alternate definitions of AKI will also be considered, as will the outcome of AKI in subgroups defined by the presence of preoperative chronic kidney disease and preoperative chronic aspirin use. At the time of randomisation, a subpopulation agreed to a single measurement of serum creatinine between 3 and 12 months after surgery, and the authors will examine intervention effects on this outcome.
  
  
  BACKGROUND
  The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this POISE-2 AKI substudy. Ethics approval was obtained for additional kidney data collection in consecutive patients enrolled at participating centres, which first began for patients enrolled after January 2011. In patients who provided consent, the remaining longer term serum creatinine data will be collected throughout 2014. The results of this study will be reported no later than 2015.
  
  
  BACKGROUND
  NCT01082874.
authors.affiliation: Western University/London Health Sciences Centre, London, Canada.
authors.forename: Amit X
authors.initials: AX
authors.lastname: Garg
authors.forename: Andrea
authors.initials: A
authors.lastname: Kurz
authors.forename: Daniel I
authors.initials: DI
authors.lastname: Sessler
authors.forename: Meaghan
authors.initials: M
authors.lastname: Cuerden
authors.forename: Andrea
authors.initials: A
authors.lastname: Robinson
authors.forename: Marko
authors.initials: M
authors.lastname: Mrkobrada
authors.forename: Chirag
authors.initials: C
authors.lastname: Parikh
authors.forename: Richard
authors.initials: R
authors.lastname: Mizera
authors.forename: Philip M
authors.initials: PM
authors.lastname: Jones
authors.forename: Maria
authors.initials: M
authors.lastname: Tiboni
authors.forename: Raul Gonzalez
authors.initials: RG
authors.lastname: Rodriguez
authors.forename: Ekaterina
authors.initials: E
authors.lastname: Popova
authors.forename: Maria Fernanda
authors.initials: MF
authors.lastname: Rojas Gomez
authors.forename: Christian S
authors.initials: CS
authors.lastname: Meyhoff
authors.forename: Tomas
authors.initials: T
authors.lastname: Vanhelder
authors.forename: Matthew T V
authors.initials: MT
authors.lastname: Chan
authors.forename: David
authors.initials: D
authors.lastname: Torres
authors.forename: Joel
authors.initials: J
authors.lastname: Parlow
authors.forename: Miriam
authors.initials: M
authors.lastname: de Nadal Clanchet
authors.forename: Mohammed
authors.initials: M
authors.lastname: Amir
authors.forename: Seyed Javad
authors.initials: SJ
authors.lastname: Bidgoli
authors.forename: Laura
authors.initials: L
authors.lastname: Pasin
authors.forename: Kristian
authors.initials: K
authors.lastname: Martinsen
authors.forename: German
authors.initials: G
authors.lastname: Malaga
authors.forename: Paul
authors.initials: P
authors.lastname: Myles
authors.forename: Rey
authors.initials: R
authors.lastname: Acedillo
authors.forename: Pavel
authors.initials: P
authors.lastname: Roshanov
authors.forename: Michael
authors.initials: M
authors.lastname: Walsh
authors.forename: George
authors.initials: G
authors.lastname: Dresser
authors.forename: Priya
authors.initials: P
authors.lastname: Kumar
authors.forename: Edith
authors.initials: E
authors.lastname: Fleischmann
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Villar
authors.forename: Tom
authors.initials: T
authors.lastname: Painter
authors.forename: Bruce
authors.initials: B
authors.lastname: Biccard
authors.forename: Sergio
authors.initials: S
authors.lastname: Bergese
authors.forename: Sadeesh
authors.initials: S
authors.lastname: Srinathan
authors.forename: Juan P
authors.initials: JP
authors.lastname: Cata
authors.forename: Vincent
authors.initials: V
authors.lastname: Chan
authors.forename: Bhupendra
authors.initials: B
authors.lastname: Mehra
authors.forename: Kate
authors.initials: K
authors.lastname: Leslie
authors.forename: Richard
authors.initials: R
authors.lastname: Whitlock
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
mesh_terms: D058186:Acute Kidney Injury / Q000097:blood / Q000517:prevention & control*; D058647:Adrenergic alpha-2 Receptor Agonists / Q000008:administration & dosage*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage*; D003000:Clonidine / Q000008:administration & dosage*; D003404:Creatinine / Q000097:blood; D005919:Glomerular Filtration Rate; D006801:Humans; D007430:Intraoperative Care; D011183:Postoperative Complications / Q000097:blood / Q000517:prevention & control*; D011300:Preoperative Care; D051436:Renal Insufficiency, Chronic / Q000150:complications; D012107:Research Design
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003404:Creatinine; D003000:Clonidine; D001241:Aspirin
keywords: Epidemiology; Surgery