Using acetaminophen to prevent kidney injury after aortic surgery
Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest
This study is testing if giving acetaminophen to patients during aortic surgery can help prevent kidney injury afterwards.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 20 Years to 100 Years |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04882202 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential protective effects of acetaminophen on acute kidney injury (AKI) in patients undergoing aortic surgery with moderate hypothermic circulatory arrest. The hypothesis is based on acetaminophen's ability to reduce lipid peroxidation caused by cell-free hemoglobin, which is associated with poor outcomes such as AKI. Participants will be randomly assigned to receive either acetaminophen or a placebo to assess the incidence of AKI post-surgery. The study aims to provide insights into improving patient outcomes following aortic surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for aortic surgery who will undergo moderate hypothermic circulatory arrest.
Not a fit: Patients with chronic kidney disease, those on dialysis, or individuals with liver cirrhosis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute kidney injury in patients undergoing aortic surgery.
How similar studies have performed: While the specific use of acetaminophen in this context is novel, similar studies have explored the protective effects of various agents on AKI, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Gangnam Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: SungYeon Ham
- Email: SYID0424@yuhs.ac
- Phone: 82-2-2019-4601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.