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
Background: 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...
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2023-07-01
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| Series: | Canadian Journal of Kidney Health and Disease |
| Online Access: | https://doi.org/10.1177/20543581231185427 |
| _version_ | 1797783030409986048 |
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| author | Amit X. Garg Meaghan Cuerden Juan Cata Matthew T. V. Chan P. J. Devereaux Edith Fleischmann Ascensión Martín Grande Barbara Kabon Giovanni Landoni Donna E. Maziak Sean McLean MD Chirag Parikh Ekaterine Popova Cara Reimer Juan Carlos Trujillo Reyes Pavel Roshanov Daniel I. Sessler Sadeesh Srinathan Jessica M. Sontrop Anna Gonzalez Tallada Michael Ke Wang Jennifer R. Wells David Conen |
| author_facet | Amit X. Garg Meaghan Cuerden Juan Cata Matthew T. V. Chan P. J. Devereaux Edith Fleischmann Ascensión Martín Grande Barbara Kabon Giovanni Landoni Donna E. Maziak Sean McLean MD Chirag Parikh Ekaterine Popova Cara Reimer Juan Carlos Trujillo Reyes Pavel Roshanov Daniel I. Sessler Sadeesh Srinathan Jessica M. Sontrop Anna Gonzalez Tallada Michael Ke Wang Jennifer R. Wells David Conen |
| author_sort | Amit X. Garg |
| collection | DOAJ |
| description | Background: 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: 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. Methods: 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 2 . Limitations: The substudy will be underpowered to detect small effects on more severe forms of acute kidney injury treated with dialysis. Results: Substudy results will be reported in 2024. Conclusions: 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 |
| first_indexed | 2024-03-13T00:20:20Z |
| format | Article |
| id | doaj.art-60645a9184ac400b939f552bd0a0b3d6 |
| institution | Directory Open Access Journal |
| issn | 2054-3581 |
| language | English |
| last_indexed | 2024-03-13T00:20:20Z |
| publishDate | 2023-07-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Canadian Journal of Kidney Health and Disease |
| spelling | doaj.art-60645a9184ac400b939f552bd0a0b3d62023-07-11T16:33:19ZengSAGE PublishingCanadian Journal of Kidney Health and Disease2054-35812023-07-011010.1177/20543581231185427Effect 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 TrialAmit X. Garg0Meaghan Cuerden1Juan Cata2Matthew T. V. Chan3P. J. Devereaux4Edith Fleischmann5Ascensión Martín Grande6Barbara Kabon7Giovanni Landoni8Donna E. Maziak9Sean McLean MD10Chirag Parikh11Ekaterine Popova12Cara Reimer13Juan Carlos Trujillo Reyes14Pavel Roshanov15Daniel I. Sessler16Sadeesh Srinathan17Jessica M. Sontrop18Anna Gonzalez Tallada19Michael Ke Wang20Jennifer R. Wells21David Conen22London Health Sciences Centre, ON, CanadaLondon Health Sciences Centre, ON, CanadaMD Anderson Cancer Center, Houston, TX, USAThe Chinese University of Hong Kong Shatin, ChinaMcMaster University, Hamilton, ON, CanadaMedical University of Vienna, AustriaHospital Universitario Ramón y Cajal, Madrid, SpainMedical University of Vienna, AustriaIRCCS San Raffaele Scientific Institute, Milan, ItalyUniversity of Ottawa, ON, CanadaVancouver Acute Department of Anesthesiology, Vancouver General Hospital, BC, CanadaJohns Hopkins School of Medicine, Baltimore, MD, USAInstitut d’Investigació Biomèdica Sant Pau, Barcelona, SpainKingston Health Sciences Centre, ON, CanadaDepartment of Thoracic Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, SpainPopulation Health Research Institute, Hamilton, ON, CanadaDepartment of Outcomes Research, Cleveland Clinic, OH, USADepartment of Surgery, University of Manitoba, Winnipeg, CanadaLondon Health Sciences Centre, ON, CanadaHospital Universitari Vall d’Hebron, Barcelona, SpainPopulation Health Research Institute, Hamilton, ON, CanadaPopulation Health Research Institute, Hamilton, ON, CanadaPopulation Health Research Institute, Hamilton, ON, CanadaBackground: 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: 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. Methods: 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 2 . Limitations: The substudy will be underpowered to detect small effects on more severe forms of acute kidney injury treated with dialysis. Results: Substudy results will be reported in 2024. Conclusions: 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: NCT03310125https://doi.org/10.1177/20543581231185427 |
| spellingShingle | Amit X. Garg Meaghan Cuerden Juan Cata Matthew T. V. Chan P. J. Devereaux Edith Fleischmann Ascensión Martín Grande Barbara Kabon Giovanni Landoni Donna E. Maziak Sean McLean MD Chirag Parikh Ekaterine Popova Cara Reimer Juan Carlos Trujillo Reyes Pavel Roshanov Daniel I. Sessler Sadeesh Srinathan Jessica M. Sontrop Anna Gonzalez Tallada Michael Ke Wang Jennifer R. Wells David Conen 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 Canadian Journal of Kidney Health and Disease |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://doi.org/10.1177/20543581231185427 |
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