Amit X Garg1, P J Devereaux2, Salim Yusuf2, Meaghan S Cuerden3, Chirag R Parikh4, Steven G Coca4, Michael Walsh2, Richard Novick5, Richard J Cook6, Anil R Jain7, Xiangbin Pan8, Nicolas Noiseux9, Karel Vik10, Noedir A Stolf11, Andrew Ritchie12, Roberto R Favaloro13, Sirish Parvathaneni14, Richard P Whitlock15, Yongning Ou16, Mitzi Lawrence16, Andre Lamy15. 1. Division of Nephrology, Department of Medicine, Western University, London, Ontario, Canada2Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada3Department of Clinical Epidemiology and Biostatistics, McMaster Universit. 2. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada4Population Health Research Institute, Hamilton, Ontario, Canada. 3. Division of Nephrology, Department of Medicine, Western University, London, Ontario, Canada5Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada. 4. Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut. 5. Division of Cardiac Surgery, Western University, London, Ontario, Canada. 6. Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada. 7. SAL Hospital and Medical Institute, Ahmadabad, India. 8. Department of Cardiovascular Surgery, Fuiwai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. 9. Department of Cardiac Surgery, Centre Hospitalier de l'Université de Montréal CHUM, Montreal, Quebec, Canada. 10. University Hospital Motol, Praha, Czech Republic. 11. Instituto do Coracao do Hospital das Clinicas da, São Paulo, Brazil. 12. Essex Cardiothoracic Centre and Anglia Ruskin University, Essex, England. 13. Department of Cardiovascular Surgery, Hospital Universitario Fundacion Favaloro, Buenos Aires, Argentina. 14. Mercy Hospital, Springfield, Missouri. 15. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada4Population Health Research Institute, Hamilton, Ontario, Canada16Division of Cardiac Surgery, McMaster University, Hamilton, Ontario, Canada. 16. Population Health Research Institute, Hamilton, Ontario, Canada.
Abstract
IMPORTANCE: Most acute kidney injury observed in the hospital is defined by sudden mild or moderate increases in the serum creatinine concentration, which may persist for several days. Such acute kidney injury is associated with lower long-term kidney function. However, it has not been demonstrated that an intervention that reduces the risk of such acute kidney injury better preserves long-term kidney function. OBJECTIVES: To characterize the risk of acute kidney injury with an intervention in a randomized clinical trial and to determine if there is a difference between the 2 treatment groups in kidney function 1 year later. DESIGN, SETTING, AND PARTICIPANTS: The Coronary ArteryBypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY) enrolled 4752 patients undergoing first isolated coronary artery bypass graft (CABG) surgery at 79 sites in 19 countries. Patients were randomized to receive CABG surgery either with a beating-heart technique (off-pump) or with cardiopulmonary bypass (on-pump). From January 2010 to November 2011, 2932 patients (from 63 sites in 16 countries) from CORONARY were enrolled into a kidney function substudy to record serum creatinine concentrations during the postoperative period and at 1 year. The last 1-year serum creatinine concentration was recorded on January 18, 2013. MAIN OUTCOMES AND MEASURES: Acute kidney injury within 30 days of surgery (≥50% increase in serum creatinine concentration from prerandomization concentration) and loss of kidney function at 1 year (≥20% loss in estimated glomerular filtration rate from prerandomization level). RESULTS: Off-pump (n = 1472) vs on-pump (n = 1460) CABG surgery reduced the risk of acute kidney injury (17.5% vs 20.8%, respectively; relative risk, 0.83 [95% CI, 0.72-0.97], P = .01); however, there was no significant difference between the 2 groups in the loss of kidney function at 1 year (17.1% vs 15.3%, respectively; relative risk, 1.10 [95% CI, 0.95-1.29], P = .23). Results were consistent with multiple alternate continuous and categorical definitions of acute kidney injury or kidney function loss, and in the subgroup with baseline chronic kidney disease. CONCLUSIONS AND RELEVANCE: Use of off-pump compared with on-pump CABG surgery reduced the risk of postoperative acute kidney injury, without evidence of better preserved kidney function with off-pump CABG surgery at 1 year. In this setting, an intervention that reduced the risk of mild to moderate acute kidney injury did not alter longer-term kidney function. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00463294.
RCT Entities:
IMPORTANCE: Most acute kidney injury observed in the hospital is defined by sudden mild or moderate increases in the serum creatinine concentration, which may persist for several days. Such acute kidney injury is associated with lower long-term kidney function. However, it has not been demonstrated that an intervention that reduces the risk of such acute kidney injury better preserves long-term kidney function. OBJECTIVES: To characterize the risk of acute kidney injury with an intervention in a randomized clinical trial and to determine if there is a difference between the 2 treatment groups in kidney function 1 year later. DESIGN, SETTING, AND PARTICIPANTS: The Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY) enrolled 4752 patients undergoing first isolated coronary artery bypass graft (CABG) surgery at 79 sites in 19 countries. Patients were randomized to receive CABG surgery either with a beating-heart technique (off-pump) or with cardiopulmonary bypass (on-pump). From January 2010 to November 2011, 2932 patients (from 63 sites in 16 countries) from CORONARY were enrolled into a kidney function substudy to record serum creatinine concentrations during the postoperative period and at 1 year. The last 1-year serum creatinine concentration was recorded on January 18, 2013. MAIN OUTCOMES AND MEASURES: Acute kidney injury within 30 days of surgery (≥50% increase in serum creatinine concentration from prerandomization concentration) and loss of kidney function at 1 year (≥20% loss in estimated glomerular filtration rate from prerandomization level). RESULTS: Off-pump (n = 1472) vs on-pump (n = 1460) CABG surgery reduced the risk of acute kidney injury (17.5% vs 20.8%, respectively; relative risk, 0.83 [95% CI, 0.72-0.97], P = .01); however, there was no significant difference between the 2 groups in the loss of kidney function at 1 year (17.1% vs 15.3%, respectively; relative risk, 1.10 [95% CI, 0.95-1.29], P = .23). Results were consistent with multiple alternate continuous and categorical definitions of acute kidney injury or kidney function loss, and in the subgroup with baseline chronic kidney disease. CONCLUSIONS AND RELEVANCE: Use of off-pump compared with on-pump CABG surgery reduced the risk of postoperative acute kidney injury, without evidence of better preserved kidney function with off-pump CABG surgery at 1 year. In this setting, an intervention that reduced the risk of mild to moderate acute kidney injury did not alter longer-term kidney function. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00463294.
Authors: Amit X Garg; Neal Badner; Sean M Bagshaw; Meaghan S Cuerden; Dean A Fergusson; Alexander J Gregory; Judith Hall; Gregory M T Hare; Boris Khanykin; Shay McGuinness; Chirag R Parikh; Pavel S Roshanov; Nadine Shehata; Jessica M Sontrop; Summer Syed; George I Tagarakis; Kevin E Thorpe; Subodh Verma; Ron Wald; Richard P Whitlock; C David Mazer Journal: J Am Soc Nephrol Date: 2019-06-20 Impact factor: 10.121
Authors: Chirag R Parikh; Dennis G Moledina; Steven G Coca; Heather R Thiessen-Philbrook; Amit X Garg Journal: Kidney Int Date: 2016-04-23 Impact factor: 10.612