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Acetaminophen and AKI After Aortic Surgery

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04882202
Collaborator
(none)
136
Enrollment
1
Location
2
Arms
27.9
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gangnam Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sung Yeon Ham, Assistant Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT04882202
Other Study ID Numbers:
  • 3-2021-0087
First Posted:
May 11, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acetaminophen

Study Results

No Results Posted as of Mar 25, 2022