Acetaminophen and AKI After Aortic Surgery

Aortic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882202
• Other study ID #: 3-2021-0087
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Gangnam Severance Hospital
• Contact: SungYeon Ham
• Phone: 82-2-2019-4601
• Email: SYID0424[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Surgery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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