Acetaminophen and AKI After Aortic Surgery

February 6, 2024 updated by: Sung Yeon Ham, Gangnam Severance Hospital

Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetaminophen group
patients receiving acetaminophen
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)
Placebo Comparator: Placebo group
patients receiving equal amount of normal saline
Other: Placebo
Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2021-0087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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