Perioperative aspirin and clonidine and risk of acute kidney injury : A randomized clinical trial
Garg, Amit X. (London Health Sciences Centre. Western University)
Kurz, Andrea (Cleveland Clinic ( Ohio, Estats Units d'Amèrica))
Sessler, Daniel I. (Cleveland Clinic ( Ohio, Estats Units d'Amèrica))
Cuerden, Meaghan (Western University (London, Canadà))
Robinson, Andrea (McMaster University. Hamilton Health Sciences Centre)
Mrkobrada, Marko (Western University (London, Canadà))
Parikh, Chirag (Yale University School of Medicine, New Haven, Connecticut, United States of America)
Mizera, Richard (McMaster University. Hamilton Health Sciences Centre)
Jones, Philip M (Western University (London, Canadà))
Tiboni, Maria (McMaster University. Hamilton Health Sciences Centre)
Font Gual, Adrià (Institut d'Investigació Biomèdica Sant Pau)
Cegarra Sanmartin, Virginia (Institut d'Investigació Biomèdica Sant Pau)
Rojas Gomez, Maria Fernanda (Fundación Oftalmológica de Santander (Bucaramanga, Colombia).)
Meyhoff, Christian S. (University of Copenhagen)
VanHelder, Tomas (McMaster University. Hamilton Health Sciences Centre)
Chan, Matthew T. V. (Chinese University of Hong Kong)
Torres, David (Clinica Santa Maria. Universidad de Los Andes)
Parlow, Joel (Kingston General Hospital, Kingston, Canada)
Nadal Clanchet, Miriam de (Hospital Universitari Vall d'Hebron)
Amir, Mohammed (Shifa International Hospitals Limited)
Bigdoli, Seyed Javad (CHU Brugmann)
Pasin, Laura (IRCCS San Raffaele Scientific Institute (Milà, Itàlia))
Martinsen, Kristian (Vejle Hospital (Vejle, Denmark))
Malaga, German (Hospital Nacional Cayetano Heredia (Lima, Peru))
Myles, Paul (Monash University (Melbourne, Australia))
Acedillo, Rey (Western University (London, Canadà))
Roshanov, Pavel (Western University (London, Canadà))
Walsh, Michael (McMaster University. Hamilton Health Sciences Centre)
Dresser, George (Western University (London, Canadà))
Kumar, Priya (University of North Carolina Medical School)
Fleischmann, Edith (Medical University of Vienna. Vienna General Hospital)
Villar, Juan Carlos (Universidad Autónoma de Bucaramanga (Bogotá, Colombia))
Painter, Thomas (Royal Adelaide Hospital (Adelaide, Australia))
Biccard, Bruce M. (Nelson R. Mandela School of Medicine)
Bergese, Sergio (Ohio State University Medical Center)
Srinathan, Sadeesh (University of Manitoba (Manitoba, Canadà))
Cata, Juan (University of Texas)
Chan, Vincent (University of Toronto)
Mehra, Bhupendra (Mahatma Gandhi Institute of Medical Sciences (Wardha, India))
Wijeysundera, Duminda N. (University of Toronto)
Leslie, Kate (Royal Melbourne Hospital (Melbourne, Australia))
Forget, Patrice (Université Catholique de Louvain (Brussels, Belgium))
Whitlock, Richard (McMaster University. Hamilton Health Sciences Centre)
Yusuf, Salim (McMaster University. Hamilton Health Sciences Centre. St. Joseph's Healthcare and the Population Health Research Institute)
Devereaux, P. J. (McMaster University. Hamilton Health Sciences Centre. St. Joseph's Healthcare and the Population Health Research Institute)
Universitat Autònoma de Barcelona. Departament de Cirurgia

Data:	2014
Resum:	IMPORTANCE: Acute kidney injury, a common complication of surgery, is associated with poor outcomes and high health care costs. Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury; however, these effects are uncertain and each intervention has the potential for harm. OBJECTIVE: To determine whether aspirin compared with placebo, and clonidine compared with placebo, alters the risk of perioperative acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS: A 2 x 2 factorial randomized, blinded, clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013. INTERVENTIONS: Patients were assigned to take aspirin (200 mg) or placebo 2 to 4 hours before surgery and then aspirin (100 mg) or placebo daily up to 30 days after surgery, and were assigned to take oral clonidine (0. 2 mg) or placebo 2 to 4 hours before surgery, and then a transdermal clonidine patch (which provided clonidine at 0. 2 mg/d) or placebo patch that remained until 72 hours after surgery. MAIN OUTCOMES AND MEASURES: Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of 0. 3mg/dL or greater (≥26. 5 μmol/L) within 48 hours of surgery or an increase of 50% or greater within 7 days of surgery. RESULTS Aspirin (n = 3443) vs placebo (n = 3462) did not alter the risk of acute kidney injury (13. 4%vs 12. 3%, respectively; adjusted relative risk, 1. 10; 95% CI, 0. 96-1. 25). Clonidine (n = 3453) vs placebo (n = 3452) did not alter the risk of acute kidney injury (13. 0% vs 12. 7%, respectively; adjusted relative risk, 1. 03; 95% CI, 0. 90-1. 18). Aspirin increased the risk of major bleeding. In a post hoc analysis, major bleeding was associated with a greater risk of subsequent acute kidney injury (23. 3% when bleeding was present vs 12. 3%when bleeding was absent; adjusted hazard ratio, 2. 20; 95% CI, 1. 72-2. 83). Similarly, clonidine increased the risk of clinically important hypotension. In a post hoc analysis, clinically important hypotension was associated with a greater risk of subsequent acute kidney injury (14. 3% when hypotensionwas present vs 11. 8% when hypotension was absent; adjusted hazard ratio, 1. 34; 95% CI, 1. 14-1. 58). CONCLUSIONS AND RELEVANCE: Among patients undergoing major noncardiac surgery, neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury. TRIAL REGISTRATION: clinicaltrials. gov Identifier: NCT01082874.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió acceptada per publicar
Matèria:	Acute Kidney Injury ; Administration, Cutaneous ; Administration, Oral ; Adrenergic alpha-2 Receptor Agonists ; Aged ; Aspirin ; Clonidine ; Creatinine ; Drug Administration Schedule ; Female ; Hemorrhage ; Humans ; Hypotension ; Male ; Middle Aged ; Perioperative Care ; Platelet Aggregation Inhibitors ; Postoperative Complications ; Risk
Publicat a:	JAMA, Vol. 312, Num. 21 (March 2014) , p. 2254-2264, ISSN 1538-3598

DOI: 10.1001/jama.2014.15284

Postprint 26 p, 1.2 MB

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