Perioperative Aspirin and Clonidine and Risk of Acute Kidney Injury A Randomized Clinical Trial
Por:
Garg, AX, Kurz, A, Sessler, DI, Cuerden, M, Robinson, A, Mrkobrada, M, Parikh, CR, Mizera, R, Jones, PM, Tiboni, M, Font, A, Cegarra, V, Gomez, MFR, Meyhoff, CS, VanHelder, T, Chan, MTV, Torres, D, Parlow, J, Clanchet, MD, Amir, M, Bidgoli, SJ, Pasin, L, Martinsen, K, Malaga, G, Myles, P, Acedillo, R, Roshanov, PS, Walsh, M, Dresser, G, Kumar, P, Fleischmann, E, Villar, JC, Painter, T, Biccard, B, Bergese, S, Srinathan, S, Cata, JP, Chan, V, Mehra, B, Wijeysundera, DN, Leslie, K, Forget, P, Whitlock, R, Yusuf, S, Devereaux, PJ
Publicada:
3 dic 2014
Resumen:
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 0.3 mg/dL or greater (>= 26.5 mu mol/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 hypotension was 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.
Filiaciones:
Garg, AX:
London Hlth Sci Ctr, London, ON N6A 4G5, Canada
Univ Western Ontario, London, ON, Canada
Kurz, A:
Cleveland Clin, Cleveland, OH 44106 USA
Sessler, DI:
Cleveland Clin, Cleveland, OH 44106 USA
Cuerden, M:
London Hlth Sci Ctr, London, ON N6A 4G5, Canada
Univ Western Ontario, London, ON, Canada
Robinson, A:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Mrkobrada, M:
London Hlth Sci Ctr, London, ON N6A 4G5, Canada
Univ Western Ontario, London, ON, Canada
Parikh, CR:
Yale Univ, Sch Med, New Haven, CT USA
Mizera, R:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Jones, PM:
London Hlth Sci Ctr, London, ON N6A 4G5, Canada
Univ Western Ontario, London, ON, Canada
Tiboni, M:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Font, A:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Cegarra, V:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Gomez, MFR:
Fdn Oftalmol Santander, Bucaramanga, Colombia
Meyhoff, CS:
Herlev Hosp, Copenhagen, Denmark
Univ Copenhagen, Copenhagen, Denmark
VanHelder, T:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Chan, MTV:
Chinese Univ Hong Kong, Hong Kong, Hong Kong, Peoples R China
Torres, D:
Univ Los Andes, Clin Santa Maria, Santiago, Chile
Parlow, J:
Kingston Gen Hosp, Kingston, ON K7L 2V7, Canada
Clanchet, MD:
Hosp Valle De Hebron, Barcelona, Spain
Amir, M:
Shifa Int Hosp Ltd, Islamabad, Pakistan
Bidgoli, SJ:
CHU Brugmann, Brussels, Belgium
Pasin, L:
Ist Sci San Raffaele, I-20132 Milan, Italy
Martinsen, K:
Vejle Hosp, Vejle, Denmark
Malaga, G:
Hosp Nacl Cayetano Heredia, Lima, Peru
Myles, P:
Monash Univ, Melbourne, Vic 3004, Australia
Acedillo, R:
London Hlth Sci Ctr, London, ON N6A 4G5, Canada
Univ Western Ontario, London, ON, Canada
Roshanov, PS:
London Hlth Sci Ctr, London, ON N6A 4G5, Canada
Univ Western Ontario, London, ON, Canada
Walsh, M:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Dresser, G:
London Hlth Sci Ctr, London, ON N6A 4G5, Canada
Univ Western Ontario, London, ON, Canada
Kumar, P:
Univ N Carolina, Sch Med, Chapel Hill, NC USA
Fleischmann, E:
Vienna Gen Hosp, Vienna, Austria
Med Univ Vienna, Vienna, Austria
Villar, JC:
Fdn Cardioinfantil, Bogota, Colombia
Univ Autonoma Bucaramanga, Bogota, Colombia
Painter, T:
Royal Adelaide Hosp, Adelaide, SA 5000, Australia
Biccard, B:
Nelson R Mandela Sch Med, Durban, South Africa
Bergese, S:
Ohio State Univ, Med Ctr, Columbus, OH 43210 USA
Srinathan, S:
Univ Manitoba, Winnipeg, MB, Canada
Cata, JP:
Univ Texas Houston, Houston, TX USA
Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
Chan, V:
Univ Hlth Network, Toronto, ON, Canada
Univ Toronto, Toronto, ON, Canada
Mehra, B:
Mahatma Gandhi Inst Med Sci, Wardha, India
Wijeysundera, DN:
Univ Hlth Network, Toronto, ON, Canada
Univ Toronto, Toronto, ON, Canada
Leslie, K:
Royal Melbourne Hosp, Melbourne, Vic, Australia
Forget, P:
Clin Univ St Luc, B-1200 Brussels, Belgium
Catholic Univ Louvain, B-1200 Brussels, Belgium
Whitlock, R:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Yusuf, S:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Devereaux, PJ:
McMaster Univ, Hamilton Hlth Sci Ctr, St Josephs Healthcare & Populat Hlth Res Inst, Hamilton, ON, Canada
Bronze
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