Effect of Colchicine on the Risk of Perioperative Acute Kidney Injury : Clinical Protocol of a Substudy of the Colchicine for the Prevention of Perioperative Atrial Fibrillation Randomized Clinical Trial
Garg, Amit X. (London Health Sciences Centre (Canadà))
Cuerden, Meaghan (London Health Sciences Centre (Canadà))
Cata, Juan (MD Anderson Cancer Center (Texas, Estatas Units d'Amèrica))
Chan, Matthew T. V. (The Chinese University of Hong Kong (Hong Kong, Xina))
Devereaux, P. J. (McMaster University (Hamilton, Canadà))
Fleischmann, Edith (Medical University of Vienna)
Martín Grande, Ascensión (Hospital Universitario Ramón y Cajal (Madrid))
Kabon, Barbara (Medical University of Vienna)
Landoni, Giovanni (IRCCS San Raffaele Scientific Institute (Milà, Itàlia))
Maziak, Donna E. (University of Ottawa (Ottawa, Canadà))
McLean, Sean (Vancouver General Hospital (Vancouver, Canadà))
Parikh, Chirag (Johns Hopkins School of Medicine (Baltimore, Estats Units d'Amèrica))
Popova, Ekaterine (Institut d'Investigació Biomèdica Sant Pau)
Reimer, Cara (Kingston Health Sciences Centre (Ontario, Canadà))
Trujillo Reyes, Juan Carlos (Institut d'Investigació Biomèdica Sant Pau)
Roshanov, Pavel (Population Health Research Institute (Ontrario, Canadà))
Sessler, Daniel I. (Cleveland Clinic (Cleveland, Estats Units d'Amèrica))
Srinathan, Sadeesh (University of Manitoba (Winnipeg, Canadà))
Sontrop, Jessica M. (London Health Sciences Centre (Canadà))
Gonzalez Tallada, Ana (Hospital Universitari Vall d'Hebron)
Wang, Michael Ke (Population Health Research Institute (Ontario, Canadà))
Wells, Jennifer R. (Population Health Research Institute (Ontario, Canadà))
Conen, David (Population Health Research Institute (Ontario, Canadà))
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	Inflammation during and after surgery can lead to organ damage including acute kidney injury. Colchicine, an established inexpensive anti-inflammatory medication, may help to protect the organs from pro-inflammatory damage. This protocol describes a kidney substudy of the colchicine for the prevention of perioperative atrial fibrillation (COP-AF) study, which is testing the effect of colchicine versus placebo on the risk of atrial fibrillation and myocardial injury among patients undergoing thoracic surgery. Objective: Our kidney substudy of COP-AF will determine whether colchicine reduces the risk of perioperative acute kidney injury compared with a placebo. We will also examine whether colchicine has a larger absolute benefit in patients with pre-existing chronic kidney disease, the most prominent risk factor for acute kidney injury. Design and Setting: Randomized, superiority clinical trial conducted in 40 centers in 11 countries from 2018 to 2023. Patients (~3200) aged 55 years and older having major thoracic surgery. Intervention: Patients are randomized 1:1 to receive oral colchicine (0. 5 mg tablet) or a matching placebo, given twice daily starting 2 to 4 hours before surgery for a total of 10 days. Patients, health care providers, data collectors, and outcome adjudicators will be blinded to the randomized treatment allocation. Serum creatinine concentrations will be measured before surgery and on postoperative days 1, 2, and 3 (or until hospital discharge). The primary outcome of the substudy is perioperative acute kidney injury, defined as an increase (from the prerandomization value) in serum creatinine concentration of either ≥26. 5 μmol/L (≥0. 3 mg/dL) within 48 hours of surgery or ≥50% within 7 days of surgery. The primary analysis (intention-to-treat) will examine the relative risk of acute kidney injury in patients allocated to receive colchicine versus placebo. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by pre-existing chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate (eGFR) <60 mL/min per 1. 73 m. The substudy will be underpowered to detect small effects on more severe forms of acute kidney injury treated with dialysis. Substudy results will be reported in 2024. This substudy will estimate the effect of colchicine on the risk of perioperative acute kidney injury in older adults undergoing major thoracic surgery. Clinical trial registration number: NCT03310125.
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 ; Colchicine ; Noncardiac surgery
Published in:	Canadian Journal of Kidney Health and Disease, Vol. 10 (1-12 2023) , ISSN 2054-3581

DOI: 10.1177/20543581231185427
PMID: 37457622

9 p, 787.4 KB

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