Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation ( POISE) 2 randomised controlled trial
Por:
Garg, AX, Kurz, A, Sessler, DI, Cuerden, M, Robinson, A, Mrkobrada, M, Parikh, C, Mizera, R, Jones, PM, Tiboni, M, Rodriguez, RG, Popova, E, Rojas Gomez, MF, 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, P, Walsh, M, Dresser, G, Kumar, P, Fleischmann, E, Villar, JC, Painter, T, Biccard, B, Bergese, S, Srinathan, S, Cata, JP, Chan, V, Mehra, B, Leslie, K, Whitlock, R, Devereaux, PJ
Publicada:
1 ene 2014
Resumen:
Introduction Perioperative Ischaemic Evaluation-2 (POISE-2) is an international 2x2 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 and analysis 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 26.5mol/L in the 2days following surgery or an increase of 50% in the 7days 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 12months after surgery, and the authors will examine intervention effects on this outcome.
Ethics and dissemination 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.
Clinical Trial Registration Number NCT01082874.
Filiaciones:
Garg, AX:
Univ Western Ontario, London Hlth Sci Ctr, London, ON, Canada
Kurz, A:
Cleveland Clin, Cleveland, OH 44106 USA
Sessler, DI:
Cleveland Clin, Cleveland, OH 44106 USA
Cuerden, M:
Univ Waterloo, Waterloo, ON N2L 3G1, Canada
Robinson, A:
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, St Josephs Healthcare, Hamilton, ON, Canada
Mrkobrada, M:
Univ Western Ontario, London Hlth Sci Ctr, London, ON, Canada
Parikh, C:
Yale Univ, New Haven, CT 06520 USA
Mizera, R:
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, St Josephs Healthcare, Hamilton, ON, Canada
Jones, PM:
Univ Western Ontario, London Hlth Sci Ctr, London, ON, Canada
Tiboni, M:
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, St Josephs Healthcare, Hamilton, ON, Canada
Rodriguez, RG:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Popova, E:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Rojas Gomez, MF:
Fdn Oftalmol Santander FOSCAL, Bucaramanga, Colombia
Meyhoff, CS:
Copenhagen Univ Hosp, Herlev, Denmark
Vanhelder, T:
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, St Josephs Healthcare, Hamilton, ON, Canada
Chan, MTV:
Chinese Univ Hong Kong, Hong Kong, Hong Kong, Peoples R China
Torres, D:
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:
Univ Western Ontario, London Hlth Sci Ctr, London, ON, Canada
Roshanov, P:
Univ Western Ontario, London Hlth Sci Ctr, London, ON, Canada
Walsh, M:
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, St Josephs Healthcare, Hamilton, ON, Canada
Dresser, G:
Univ Western Ontario, London Hlth Sci Ctr, London, ON, Canada
Kumar, P:
Univ N Carolina, Sch Med, Chapel Hill, NC USA
Fleischmann, E:
Med Univ Vienna, Vienna Gen Hosp, Vienna, Austria
Villar, JC:
FCI, 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 MD Anderson Canc Ctr, Houston, TX 77030 USA
Chan, V:
Univ Toronto, Toronto, ON, Canada
Mehra, B:
Mahatma Gandhi Inst Med Sci, Wardha, Maharashtra, India
Leslie, K:
Royal Melbourne Hosp, Melbourne, Vic, Australia
Whitlock, R:
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, St Josephs Healthcare, Hamilton, ON, Canada
Devereaux, PJ:
McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, St Josephs Healthcare, Hamilton, ON, Canada
Gold, Green Published
|