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 AX 1 , Cuerden M 1 , Aguado H 2 , Amir M 3 , Belley-Cote EP 4 , Bhatt K 5 Show all authors , Biccard BM 6 , Borges FK 7 , Chan M 8 , Conen D 7 , Duceppe E 7 , Efremov S 9 , Eikelboom J 4 , Fleischmann E 10 , Giovanni L 11 , Gross P 4 , Jayaram R 12 , Kirov M 13 , Kleinlugtenbelt Y 14 , Kurz A 15 , Lamy A 7 , Leslie K 16 , Likhvantsev V 17 , Lomivorotov V 18 , Marcucci M 4 , Martínez-Zapata MJ 19 , McGillion M 4 , McIntyre W 7 , Meyhoff C 20 , Ofori S 7 , Painter T 21 , Paniagua P 22 , Parikh C 23 , Parlow J 24 , Patel A 4 , Polanczyk C 25 , Richards T 26 , Roshanov P 27 , Schmartz D 28 , Sessler D 29 , Short T 30 , Sontrop JM 27 , Spence J 4 , Srinathan S 31 , Stillo D 7 , Szczeklik W 32 , Tandon V 4 , Torres D 33 , Van Helder T 34 , Vincent J 7 , Wang CY 35 , Wang M 4 , Whitlock R 7 , Wittmann M 36 , Xavier D 37 , Devereaux PJ 4

Affiliations 

  • 1 London Health Sciences Centre, ON, Canada
  • 2 Hospital Clínico Universitario de Valladolid, Spain
  • 3 Shifa International Hospital (STMU), Islamabad, Pakistan
  • 4 McMaster University, Hamilton, ON, Canada
  • 5 SIDS Hospital & Research Centre, Guntur, India
  • 6 Groote Schuur Hospital, Cape Town, South Africa
  • 7 Population Health Research Institute, Hamilton, ON, Canada
  • 8 The Chinese University of Hong Kong, Shatin, Hong Kong
  • 9 Saint Petersburg State University, Russia
  • 10 Medical University of Vienna, Austria
  • 11 Istituto Scientifico Universitario San Raffaele, Milan, Italy
  • 12 University of Oxford, UK
  • 13 Northern State Medical University of the Ministry of Healthcare of the Russian Federation, Arkhangelsk, Russia
  • 14 Deventer Ziekenhuis, The Netherlands
  • 15 Medical University of Graz, Austria
  • 16 The Royal Melbourne Hospital, VIC, Austria
  • 17 I. M. Sechenov Moscow Medical Academy, Russia
  • 18 Novosibirsk State University, Russia
  • 19 Centro Cochrane Iberoamericano, Barcelona, Spain
  • 20 University of Copenhagen, Denmark
  • 21 Royal Adelaide Hospital, SA, Australia
  • 22 Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
  • 23 Johns Hopkins University, Baltimore, MD, USA
  • 24 Kingston General Hospital, ON, Canada
  • 25 Hospital de Clinicas de Porto Alegre, Brazil
  • 26 The University of Western Australia, Perth, Australia
  • 27 Western University, London, ON, Canada
  • 28 CHU Brugmann, Brussels, Belgium
  • 29 Cleveland Clinic, OH, USA
  • 30 Auckland District Health Board, New Zealand
  • 31 University of Manitoba, Winnipeg, Canada
  • 32 Jagiellonian University, Krakow, Poland
  • 33 Clinica Santa Maria, Santiago, Chile
  • 34 Hamilton Health Sciences, ON, Canada
  • 35 University of Malaya, Kuala Lumpur, Malaysia
  • 36 Universitätsklinikum Bonn, Germany
  • 37 St. John's National Academy of Health Sciences, Bangalore, India
Can J Kidney Health Dis, 2022;9:20543581211069225.
PMID: 35024154 DOI: 10.1177/20543581211069225

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 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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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