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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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, C. Y.; Wang, Michael; Whitlock, Richard; Wittmann, Maria; Xavier, Denis; Devereaux, P. J.
In: Canadian Journal of Kidney Health and Disease, Vol. 9, 2022, p. 1-9.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury
T2 - A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial
AU - Garg, Amit X.
AU - Cuerden, Meaghan
AU - Aguado, Hector
AU - Amir, Mohammed
AU - Belley-Cote, Emilie P
AU - Bhatt, Keyur
AU - Biccard, Bruce M.
AU - Borges, Flavia K.
AU - Chan, Matthew
AU - Conen, David
AU - Duceppe, Emmanuelle
AU - Efremov, Sergey
AU - Eikelboom, John
AU - Fleischmann, Edith
AU - Giovanni, Landoni
AU - Gross, Peter
AU - Jayaram, Raja
AU - Kirov, Mikhail
AU - Kleinlugtenbelt, Ydo
AU - Kurz, Andrea
AU - Lamy, Andre
AU - Leslie, Kate
AU - Likhvantsev, Valery
AU - Lomivorotov, Vladimir
AU - Marcucci, Maura
AU - Martínez-Zapata, Maria José
AU - McGillion, Michael
AU - McIntyre, William
AU - Meyhoff, Christian
AU - Ofori, Sandra
AU - Painter, Thomas
AU - Paniagua, Pilar
AU - Parikh, Chirag
AU - Parlow, Joel
AU - Patel, Ameen
AU - Polanczyk, Carisi
AU - Richards, Toby
AU - Roshanov, Pavel
AU - Schmartz, Denis
AU - Sessler, Daniel
AU - Short, Tim
AU - Sontrop, Jessica M.
AU - Spence, Jessica
AU - Srinathan, Sadeesh
AU - Stillo, David
AU - Szczeklik, Wojciech
AU - Tandon, Vikas
AU - Torres, David
AU - Van Helder, Thomas
AU - Vincent, Jessica
AU - Wang, C. Y.
AU - Wang, Michael
AU - Whitlock, Richard
AU - Wittmann, Maria
AU - Xavier, Denis
AU - Devereaux, P. J.
N1 - Publisher Copyright: © The Author(s) 2022.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - acute kidney injury
KW - antihypertensive medication
KW - hypotension
KW - mean arterial pressure
KW - noncardiac surgery
U2 - 10.1177/20543581211069225
DO - 10.1177/20543581211069225
M3 - Journal article
C2 - 35024154
AN - SCOPUS:85122518044
VL - 9
SP - 1
EP - 9
JO - Canadian Journal of Kidney Health and Disease
JF - Canadian Journal of Kidney Health and Disease
SN - 2054-3581
ER -
ID: 316415461