Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial
Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes...
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2022
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R Medicine Garg, Amit X. Cuerden, Meaghan Aguado, Hector Amir, Mohammed Belley-Cote, Emilie P. Bhatt, Keyur Biccard, Bruce M. Borges, Flavia K. Chan, Matthew Conen, David Duceppe, Emmanuelle Efremov, Sergey Eikelboom, John Fleischmann, Edith Giovanni, Landoni Gross, Peter Jayaram, Raja Kirov, Mikhail Kleinlugtenbelt, Ydo Kurz, Andrea Lamy, Andre Leslie, Kate Likhvantsev, Valery Lomivorotov, Vladimir Marcucci, Maura Martínez-Zapata, Maria José McGillion, Michael McIntyre, William Meyhoff, Christian Ofori, Sandra Painter, Thomas Paniagua, Pilar Parikh, Chirag Parlow, Joel Patel, Ameen Polanczyk, Carisi Richards, Toby Roshanov, Pavel Schmartz, Denis Sessler, Daniel Short, Tim Sontrop, Jessica M. Spence, Jessica Srinathan, Sadeesh Stillo, David Szczeklik, Wojciech Tandon, Vikas Torres, David Van Helder, Thomas Vincent, Jessica Wang, Chew Yin Wang, Michael Whitlock, Richard Wittmann, Maria Xavier, Denis Devereaux, P.J. Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial |
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Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery. Objective: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy. Design: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy). Intervention: If the presurgery systolic blood pressure (SBP) is <130 mmHg, all antihypertensive medications are withheld on the morning of surgery. If the SBP is ≥130 mmHg, some medications (but not angiotensin receptor blockers ACEIs, angiotensin receptor blockers ARBs, or renin inhibitors) may be continued in a stepwise manner. During surgery, the patients’ mean arterial pressure (MAP) is maintained at ≥80 mmHg. During the first 48 hours after surgery, some antihypertensive medications (but not ACEIs, ARBs, or renin inhibitors) may be restarted in a stepwise manner if the SBP is ≥130 mmHg. Control: Patients receive their usual antihypertensive medications before and after surgery. The patients’ MAP is maintained at ≥60 mmHg from anesthetic induction until the end of surgery. Setting: Recruitment from 108 centers in 22 countries from 2018 to 2021. Patients: Patients (~6800) aged ≥45 years having noncardiac surgery who have or are at risk of atherosclerotic disease and who routinely take antihypertensive medications. Measurements: The primary outcome of the substudy is postoperative acute kidney injury, defined as an increase in serum creatinine concentration of either ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours of randomization or ≥50% within 7 days of randomization. Methods: The primary analysis (intention-to-treat) will examine the relative risk and 95% confidence interval of acute kidney injury in the intervention versus control group. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by preexisting chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate <60 mL/min/1.73 m2. Results: Substudy results will be analyzed in 2022. Limitations: It is not possible to mask patients or providers to the intervention; however, objective measures will be used to assess acute kidney injury. Conclusions: This substudy will provide generalizable estimates of the effect of a perioperative hypotension-avoidance strategy on the risk of acute kidney injury. © The Author(s) 2022. |
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Article |
| author |
Garg, Amit X. Cuerden, Meaghan Aguado, Hector Amir, Mohammed Belley-Cote, Emilie P. Bhatt, Keyur Biccard, Bruce M. Borges, Flavia K. Chan, Matthew Conen, David Duceppe, Emmanuelle Efremov, Sergey Eikelboom, John Fleischmann, Edith Giovanni, Landoni Gross, Peter Jayaram, Raja Kirov, Mikhail Kleinlugtenbelt, Ydo Kurz, Andrea Lamy, Andre Leslie, Kate Likhvantsev, Valery Lomivorotov, Vladimir Marcucci, Maura Martínez-Zapata, Maria José McGillion, Michael McIntyre, William Meyhoff, Christian Ofori, Sandra Painter, Thomas Paniagua, Pilar Parikh, Chirag Parlow, Joel Patel, Ameen Polanczyk, Carisi Richards, Toby Roshanov, Pavel Schmartz, Denis Sessler, Daniel Short, Tim Sontrop, Jessica M. Spence, Jessica Srinathan, Sadeesh Stillo, David Szczeklik, Wojciech Tandon, Vikas Torres, David Van Helder, Thomas Vincent, Jessica Wang, Chew Yin Wang, Michael Whitlock, Richard Wittmann, Maria Xavier, Denis Devereaux, P.J. |
| author_facet |
Garg, Amit X. Cuerden, Meaghan Aguado, Hector Amir, Mohammed Belley-Cote, Emilie P. Bhatt, Keyur Biccard, Bruce M. Borges, Flavia K. Chan, Matthew Conen, David Duceppe, Emmanuelle Efremov, Sergey Eikelboom, John Fleischmann, Edith Giovanni, Landoni Gross, Peter Jayaram, Raja Kirov, Mikhail Kleinlugtenbelt, Ydo Kurz, Andrea Lamy, Andre Leslie, Kate Likhvantsev, Valery Lomivorotov, Vladimir Marcucci, Maura Martínez-Zapata, Maria José McGillion, Michael McIntyre, William Meyhoff, Christian Ofori, Sandra Painter, Thomas Paniagua, Pilar Parikh, Chirag Parlow, Joel Patel, Ameen Polanczyk, Carisi Richards, Toby Roshanov, Pavel Schmartz, Denis Sessler, Daniel Short, Tim Sontrop, Jessica M. Spence, Jessica Srinathan, Sadeesh Stillo, David Szczeklik, Wojciech Tandon, Vikas Torres, David Van Helder, Thomas Vincent, Jessica Wang, Chew Yin Wang, Michael Whitlock, Richard Wittmann, Maria Xavier, Denis Devereaux, P.J. |
| author_sort |
Garg, Amit X. |
| title |
Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial |
| title_short |
Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial |
| title_full |
Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial |
| title_fullStr |
Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial |
| title_full_unstemmed |
Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial |
| title_sort |
effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial |
| publisher |
SAGE Publications Ltd |
| publishDate |
2022 |
| url |
http://eprints.um.edu.my/43163/ https://www.scopus.com/inward/record.uri?eid=2-s2.0-85122518044&doi=10.1177%2f20543581211069225&partnerID=40&md5=b9f66e3970ebe6a6eec1dbfcd7945b5b |
| _version_ |
1781704669991534592 |
| spelling |
my.um.eprints.431632023-10-09T05:16:01Z http://eprints.um.edu.my/43163/ Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial Garg, Amit X. Cuerden, Meaghan Aguado, Hector Amir, Mohammed Belley-Cote, Emilie P. Bhatt, Keyur Biccard, Bruce M. Borges, Flavia K. Chan, Matthew Conen, David Duceppe, Emmanuelle Efremov, Sergey Eikelboom, John Fleischmann, Edith Giovanni, Landoni Gross, Peter Jayaram, Raja Kirov, Mikhail Kleinlugtenbelt, Ydo Kurz, Andrea Lamy, Andre Leslie, Kate Likhvantsev, Valery Lomivorotov, Vladimir Marcucci, Maura Martínez-Zapata, Maria José McGillion, Michael McIntyre, William Meyhoff, Christian Ofori, Sandra Painter, Thomas Paniagua, Pilar Parikh, Chirag Parlow, Joel Patel, Ameen Polanczyk, Carisi Richards, Toby Roshanov, Pavel Schmartz, Denis Sessler, Daniel Short, Tim Sontrop, Jessica M. Spence, Jessica Srinathan, Sadeesh Stillo, David Szczeklik, Wojciech Tandon, Vikas Torres, David Van Helder, Thomas Vincent, Jessica Wang, Chew Yin Wang, Michael Whitlock, Richard Wittmann, Maria Xavier, Denis Devereaux, P.J. R Medicine Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery. Objective: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy. Design: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy). Intervention: If the presurgery systolic blood pressure (SBP) is <130 mmHg, all antihypertensive medications are withheld on the morning of surgery. If the SBP is ≥130 mmHg, some medications (but not angiotensin receptor blockers ACEIs, angiotensin receptor blockers ARBs, or renin inhibitors) may be continued in a stepwise manner. During surgery, the patients’ mean arterial pressure (MAP) is maintained at ≥80 mmHg. During the first 48 hours after surgery, some antihypertensive medications (but not ACEIs, ARBs, or renin inhibitors) may be restarted in a stepwise manner if the SBP is ≥130 mmHg. Control: Patients receive their usual antihypertensive medications before and after surgery. The patients’ MAP is maintained at ≥60 mmHg from anesthetic induction until the end of surgery. Setting: Recruitment from 108 centers in 22 countries from 2018 to 2021. Patients: Patients (~6800) aged ≥45 years having noncardiac surgery who have or are at risk of atherosclerotic disease and who routinely take antihypertensive medications. Measurements: The primary outcome of the substudy is postoperative acute kidney injury, defined as an increase in serum creatinine concentration of either ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours of randomization or ≥50% within 7 days of randomization. Methods: The primary analysis (intention-to-treat) will examine the relative risk and 95% confidence interval of acute kidney injury in the intervention versus control group. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by preexisting chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate <60 mL/min/1.73 m2. Results: Substudy results will be analyzed in 2022. Limitations: It is not possible to mask patients or providers to the intervention; however, objective measures will be used to assess acute kidney injury. Conclusions: This substudy will provide generalizable estimates of the effect of a perioperative hypotension-avoidance strategy on the risk of acute kidney injury. © The Author(s) 2022. SAGE Publications Ltd 2022-01 Article PeerReviewed Garg, Amit X. and Cuerden, Meaghan and Aguado, Hector and Amir, Mohammed and Belley-Cote, Emilie P. and Bhatt, Keyur and Biccard, Bruce M. and Borges, Flavia K. and Chan, Matthew and Conen, David and Duceppe, Emmanuelle and Efremov, Sergey and Eikelboom, John and Fleischmann, Edith and Giovanni, Landoni and Gross, Peter and Jayaram, Raja and Kirov, Mikhail and Kleinlugtenbelt, Ydo and Kurz, Andrea and Lamy, Andre and Leslie, Kate and Likhvantsev, Valery and Lomivorotov, Vladimir and Marcucci, Maura and Martínez-Zapata, Maria José and McGillion, Michael and McIntyre, William and Meyhoff, Christian and Ofori, Sandra and Painter, Thomas and Paniagua, Pilar and Parikh, Chirag and Parlow, Joel and Patel, Ameen and Polanczyk, Carisi and Richards, Toby and Roshanov, Pavel and Schmartz, Denis and Sessler, Daniel and Short, Tim and Sontrop, Jessica M. and Spence, Jessica and Srinathan, Sadeesh and Stillo, David and Szczeklik, Wojciech and Tandon, Vikas and Torres, David and Van Helder, Thomas and Vincent, Jessica and Wang, Chew Yin and Wang, Michael and Whitlock, Richard and Wittmann, Maria and Xavier, Denis and Devereaux, P.J. (2022) Effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury : a clinical research protocol for a substudy of the poise-3 randomized clinical trial. Canadian Journal of Kidney Health and Disease, 9. ISSN 2054-3581, DOI https://doi.org/10.1177/20543581211069225 <https://doi.org/10.1177/20543581211069225>. https://www.scopus.com/inward/record.uri?eid=2-s2.0-85122518044&doi=10.1177%2f20543581211069225&partnerID=40&md5=b9f66e3970ebe6a6eec1dbfcd7945b5b 10.1177/20543581211069225 |
| score |
13.211869 |