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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04882202

Enrollment

136

Registered

2021-05-11

Start date

2021-10-01

Completion date

2024-12-30

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Surgery

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.

Interventions

DRUGAcetaminophen

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)

OTHERPlacebo

Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

Inclusion criteria

1\) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.

Exclusion criteria

1. patients with chronic kidney disease or with dialysis, eGFR \< 15ml/min/1.73m2 2. allergy to acetaminophen or propacetamol HCl 3. history of liver cirrhosis or total bilirubin \> 2.0mg/dL 3\) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent

Design outcomes

Primary

Measure	Time frame	Description
Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest	Postoperative 7 days	Compare the incidence of acute kidney injury within 7 days after surgery. Acute kidney injury is defined using KDIGO criteria.

Countries

South Korea

Contacts

Primary ContactSungYeon Ham

SYID0424@yuhs.ac82-2-2019-4601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026