Acetaminophen and AKI After Aortic Surgery
Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest
1 other identifier
interventional
136
1 country
1
Brief Summary
Acute kidney injury is commonly accompanied major complication after aortic surgery. Cardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. This increases plasma free hemoglobin, F2-isoprostane, and isofuran concentration. Cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death. Acetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. Thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedFebruary 7, 2024
February 1, 2024
3.2 years
May 6, 2021
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest
Compare the incidence of acute kidney injury within 7 days after surgery. Acute kidney injury is defined using KDIGO criteria.
Postoperative 7 days
Study Arms (2)
Acetaminophen group
EXPERIMENTALpatients receiving acetaminophen
Placebo group
PLACEBO COMPARATORpatients receiving equal amount of normal saline
Interventions
Acetaminophen 1g IV every 6 hours for a weight \> 50kg (maximum of 4g per 24 hours) or 15mg/kg every 6 hours for a weight \< 50kg (maximum of 75mg/kg per 24 hours)
Eligibility Criteria
You may qualify if:
- \) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.
You may not qualify if:
- patients with chronic kidney disease or with dialysis, eGFR \< 15ml/min/1.73m2
- allergy to acetaminophen or propacetamol HCl
- history of liver cirrhosis or total bilirubin \> 2.0mg/dL
- \) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gangnam Severance Hospital
Seoul, South Korea
Related Publications (1)
Simpson SA, Zaccagni H, Bichell DP, Christian KG, Mettler BA, Donahue BS, Roberts LJ 2nd, Pretorius M. Acetaminophen attenuates lipid peroxidation in children undergoing cardiopulmonary bypass. Pediatr Crit Care Med. 2014 Jul;15(6):503-10. doi: 10.1097/PCC.0000000000000149.
PMID: 24732290BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 11, 2021
Study Start
October 1, 2021
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
February 7, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share