Acetaminophen and AKI After Aortic Surgery

Not Applicable

Recruiting

• Conditions: Aortic Surgery
• Interventions: Other: Placebo; Drug: Acetaminophen

• Registration Number: NCT04882202
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-11
• Study Start: 2021-10-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	patients receiving equal amount of normal saline
Acetaminophen group	Acetaminophen	patients receiving acetaminophen

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of