Authors : Amit X Garg, Meaghan Cuerden, Richard Whitlock, Maria Wittmann, *Denis Xavier*, PJ Devereaux, Hector Aguado, Mohammed Amir, Emilie P Belley-Cote, Keyur Bhatt, Bruce M Biccard Michael McGillion, William McIntyre, Christian Meyhoff, Sandra Ofori, Thomas Painter, Pilar Paniagua, Chirag Parikh, Joel Parlow, Ameen Patel, Carisi Polanczyk, Toby Richards, Pavel Roshanov, et al.
Publication Year : 2022
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.
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.
Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy).
If the presurgery systolic blood pressure (SBP) is <130>
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.
Recruitment from 108 centers in 22 countries from 2018 to 2021.
Patients (~6800) aged ?45 years having noncardiac surgery who have or are at risk of atherosclerotic disease and who routinely take antihypertensive medications.
The primary outcome of the substudy is postoperative acute kidney injury, defined as an increase in serum creatinine concentration of either ?26.5 ?mol/L (?0.3 mg/dL) within 48 hours of randomization or ?50% within 7 days of randomization.
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>2.
Substudy results will be analyzed in 2022.
It is not possible to mask patients or providers to the intervention; however, objective measures will be used to assess acute kidney injury.
This substudy will provide generalizable estimates of the effect of a perioperative hypotension-avoidance strategy on the risk of acute kidney injury.