Aortic SurgeryNCT04882202
Acetaminophen and AKI After Aortic Surgery
A study testing Acetaminophen in people with Aortic Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Aortic Surgery
- What is being tested?
- Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.
Who cannot join
- patients with chronic kidney disease or with dialysis, eGFR < 15ml/min/1.73m2
- allergy to acetaminophen or propacetamol HCl
- history of liver cirrhosis or total bilirubin > 2.0mg/dL
- 3) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
SungYeon Ham, 82-2-2019-4601, SYID0424@yuhs.ac
About this study
Official title: Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest
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.
- Conditions
- Aortic Surgery
- Being tested
- Acetaminophen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
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)
PlaceboOther
Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen group | Experimental | patients receiving acetaminophen Receives: Drug: Acetaminophen |
| Placebo group | Placebo comparator | patients receiving equal amount of normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Oct 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yeon Ham, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882202
- Sponsor's protocol ID
- 3-2021-0087
- Status last verified
- Feb 2024
- First submitted
- 6 May 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24732290
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest
- ClinicalTrials.gov ID
- NCT04882202
- Acronym / sponsor ID
- 3-2021-0087
- Conditions
- Aortic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen group | Experimental | Drug: Acetaminophenpatients receiving acetaminophen |
| Placebo group | Placebo comparator | Other: Placebopatients receiving equal amount of normal saline |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.
Key exclusion criteria (4 listed)
- patients with chronic kidney disease or with dialysis, eGFR < 15ml/min/1.73m2
- allergy to acetaminophen or propacetamol HCl
- history of liver cirrhosis or total bilirubin > 2.0mg/dL
- 3) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAcetaminophen 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) | Drug | Acetaminophen group |
| PlaceboNormal saline 100 ml (equal amount of acetaminophen) IV every 6 hours | Other | Placebo group |
Primary outcome
Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest
Time frame: Postoperative 7 days
Compare the incidence of acute kidney injury within 7 days after surgery. Acute kidney injury is defined using KDIGO criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 24732290Simpson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen in people with Aortic Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SungYeon Ham (82-2-2019-4601, SYID0424@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.