Acetaminophen and AKI After Aortic Surgery

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Aortic Surgery

Treatments: Other: Placebo; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04882202

3-2021-0087

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

Acetaminophen group

Experimental group

Description:

patients receiving acetaminophen

Treatment:

Drug: Acetaminophen

Placebo group

Placebo Comparator group

Description:

patients receiving equal amount of normal saline

Treatment:

Other: Placebo