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. (London Health Sciences Centre)
Cuerden, Meaghan (London Health Sciences Centre)
Aguado, Héctor J (Hospital Clínico Universitario de Valladolid)
Amir, Mohammed (Shifa International Hospital)
Belley-Cote, Emilie P. (McMaster University (Canadà))
Bhatt, Keyur (SIDS Hospital Research Centre)
Biccard, Bruce M (Groote Schuur Hospital (Observatory, Sud-àfrica))
Borges, Flavia K. (Population Health Research Institute)
Chan, Matthew (The Chinese University of Hong Kong)
Conen, David (Population Health Research Institute)
Duceppe, Emmanuelle (Population Health Research Institute)
Efremov, Sergey (Saint Petersburg State University)
Eikelboom, John (McMaster University (Canadà))
Fleischmann, Edith (Medical University of Vienna)
Giovanni, Landoni (Istituto Scientifico Universitario San Raffaele)
Gross, Peter (McMaster University (Canadà))
Jayaram, Raja (University of Oxford)
Kirov, Mikhail (Northern State Medical University of the Ministry of Healthcare of the Russian Federation)
Kleinlugtenbelt, Ydo (Deventer Ziekenhuis)
Kurz, Andrea (Medical University of Graz)
Lamy, Andre (Population Health Research Institute)
Leslie, Kate (The Royal Melbourne Hospital)
Likhvantsev, Valery (I. M. Sechenov Moscow Medical Academy)
Lomivorotov, Vladimir (Novosibirsk State University)
Marcucci, Maura (McMaster University (Canadà))
Martinez-Zapata, Maria José (Institut d'Investigació Biomèdica Sant Pau)
McGillion, Michael (McMaster University (Canadà))
McIntyre, William (Population Health Research Institute)
Meyhoff, Christian (University of Copenhagen)
Ofori, Sandra (Population Health Research Institute)
Painter, Thomas (Royal Adelaide Hospital)
Paniagua, Pilar (Institut d'Investigació Biomèdica Sant Pau)
Parikh, Chirag (Johns Hopkins University)
Parlow, Joel (Kingston General Hospital)
Patel, Ameen (McMaster University (Canadà))
Polanczyk, Carisi (Hospital de Clínicas de Porto Alegre (Brasil))
Richards, Toby (The University of Western Australia)
Roshanov, Pavel (Western University)
Schmartz, Denis (CHU Brugmann)
Sessler, Daniel (Cleveland Clinic)
Short, Tim (Auckland District Health Board)
Sontrop, Jessica M. (Western University)
Spence, Jessica (McMaster University (Canadà))
Srinathan, Sadeesh (University of Manitoba)
Stillo, David (Population Health Research Institute)
Szczeklik, Wojciech (Jagiellonian University)
Tandon, Vikas (McMaster University (Canadà))
Torres, David (Clinica Santa Maria (Chile))
Van Helder, Thomas (Hamilton Health Sciences)
Vincent, Jessica (Population Health Research Institute)
Wang, C.Y. (University of Malaya)
Wang, Michael Ke (McMaster University (Canadà))
Whitlock, Richard (Population Health Research Institute)
Wittmann, Maria (Universitätsklinikum Bonn)
Xavier, Denis (St. John's National Academy of Health Sciences)
Devereaux, P. J (McMaster University (Canadà))

Date:	2022
Abstract:	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 m. 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.
Grants:	Instituto de Salud Carlos III CP1120/00023
Note:	Altres ajuts: The Canadian Institutes of Health Research; the Australian National Health; Medical Research Council (NHMRC); The Kidney Foundation of Canada; the Department of Medicine at Western University; McMaster University Department of Medicine Career Research Award; the Australian NHMRC (APP1162362); the Research Grants Council of Hong Kong, General Research Fund (14104419); Tier 1 Canada Research Chair in Perioperative Medicine; the Dr Adam Linton Chair in Kidney Health Analytics; Clinician Investigator Salary Award from the Canadian Institutes of Health Research; the Medical and Health Research Infrastructure Fund; the Western University Resident Research Fellowship Program.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Acute kidney injury ; Antihypertensive medication ; Hypotension ; Mean arterial pressure ; Noncardiac surgery
Published in:	Canadian Journal of Kidney Health and Disease, Vol. 9 (january 2022) , ISSN 2054-3581

DOI: 10.1177/20543581211069225
PMID: 35024154

9 p, 318.7 KB

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