Acetaminophen and AKI After Aortic Surgery

NCT04882202 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Aortic Surgery

Interventions

DRUG

Acetaminophen

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)

OTHER

Placebo

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

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882202 on ClinicalTrials.gov