Uric AcidNCT07044934
Uric Acid and Menopausal Age in Acute Kidney Injury
An observational study of Uric Acid, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Preoperative serum uric acid significantly impacted acute kidney injury in female patients undergoing non-cardiac surgery, with differential effects observed before and after menopause. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uric Acid
- How many people
- 127,052 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2024to 20 Feb 2025
- Phase
- Observational
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: This study included female patients aged 18 years or older who underwent elective non-cardiac surgery at a tertiary medical center. For patients who underwent multiple surgeries during the study period, only the first procedure following hospital admission was analyzed. The exclusion criteria were as follows: patients with a history of gout; those who had undergone nephrectomy or kidney transplantation (either as donors or recipients); patients diagnosed with chronic kidney disease or those who had received kidney replacement therapy; patients with an estimated glomerular filtration rate of less than 30 mL/min/1.73 m²; and those with incomplete clinical data or missing laboratory values.
Who may be able to join
- Female patients aged 18 years and older who underwent elective non-cardiac surgery
Who cannot join
- Patients with gout
- Patients who underwent nephrectomy or kidney transplantation (either as recipients or donors)
- Patients diagnosed with chronic kidney disease or who had already undergone kidney replacement therapy
- Patients with estimated glomerular filtration rate < 30 mL/min/1.73m²; and patients with incomplete data or missing laboratory values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Preoperative Uric Acid on Postoperative Acute Kidney Injury in Female Patients Undergoing Non-cardiac Surgery
Preoperative serum uric acid significantly impacted acute kidney injury in female patients undergoing non-cardiac surgery, with differential effects observed before and after menopause.
Read the detailed description
Preoperative serum uric acid has been increasingly recognized as a potential biomarker associated with acute kidney injury in various clinical settings. However, the sex-specific and hormonal influences on this association remain unclear, particularly in the context of non-cardiac surgery. Female patients, who experience significant physiological changes across the menopausal transition, may exhibit different renal susceptibilities to elevated serum uric acid levels.
In this retrospective cohort study, the investigators aimed to evaluate the association between preoperative serum uric acid levels and postoperative acute kidney injury in female patients undergoing non-cardiac surgery, with a particular focus on menopausal status. Women were stratified into premenopausal and postmenopausal groups based on age and clinical criteria. The investigators hypothesized that the threshold and pattern of serum uric acid-associated acute kidney injury risk may differ between these two populations due to differences in hormonal status and baseline renal reserve.
- Conditions
- Uric Acid
- Being tested
- No Intervention: Observational Cohort
- Keywords
- uric acid, female, non cardiac, acute kindeny injury, menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This observational cohort includes female patients undergoing non-cardiac surgery. No intervention was administered as part of the study protocol. Preoperative serum uric acid levels were measured, and patients were followed for the development of postoperative acute kidney injury. Data were analyzed retrospectively to assess the association between uric acid levels and acute kidney injury, with subgroup analyses based on menopausal status (premenopausal vs. postmenopausal women).
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Women | Not described Receives: Other: No Intervention: Observational Cohort | |
| Postmenopausal Women | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Acute Kidney Injury
Measured: 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 Jul 2024
- Primary completion20 Dec 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uric AcidStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hoon Sim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044934
- Sponsor's protocol ID
- AMC [2024-1090]
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Individual data sharing
- No: The dataset used and/or analyzed during the current study is available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Uric Acid on Postoperative Acute Kidney Injury in Female Patients Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT07044934
- Acronym / sponsor ID
- AMC [2024-1090]
- Conditions
- Uric Acid
- Keywords
- uric acid, female, non cardiac, acute kindeny injury, menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127,052 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 1 Jul 2025 (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.
Preoperative serum uric acid significantly impacted acute kidney injury in female patients undergoing non-cardiac surgery, with differential effects observed before and after menopause.
Detailed description
Preoperative serum uric acid has been increasingly recognized as a potential biomarker associated with acute kidney injury in various clinical settings. However, the sex-specific and hormonal influences on this association remain unclear, particularly in the context of non-cardiac surgery. Female patients, who experience significant physiological changes across the menopausal transition, may exhibit different renal susceptibilities to elevated serum uric acid levels.
In this retrospective cohort study, the investigators aimed to evaluate the association between preoperative serum uric acid levels and postoperative acute kidney injury in female patients undergoing non-cardiac surgery, with a particular focus on menopausal status. Women were stratified into premenopausal and postmenopausal groups based on age and clinical criteria. The investigators hypothesized that the threshold and pattern of serum uric acid-associated acute kidney injury risk may differ between these two populations due to differences in hormonal status and baseline renal reserve.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Women | – | Other: No Intervention: Observational Cohort |
| Postmenopausal Women | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- This study included female patients aged 18 years or older who underwent elective non-cardiac surgery at a tertiary medical center. For patients who underwent multiple surgeries during the study period, only the first procedure following hospital admission was analyzed. The exclusion criteria were as follows: patients with a history of gout; those who had undergone nephrectomy or kidney transplantation (either as donors or recipients); patients diagnosed with chronic kidney disease or those who had received kidney replacement therapy; patients with an estimated glomerular filtration rate of less than 30 mL/min/1.73 m²; and those with incomplete clinical data or missing laboratory values.
Key inclusion criteria (1 listed)
- Female patients aged 18 years and older who underwent elective non-cardiac surgery
Key exclusion criteria (4 listed)
- Patients with gout
- Patients who underwent nephrectomy or kidney transplantation (either as recipients or donors)
- Patients diagnosed with chronic kidney disease or who had already undergone kidney replacement therapy
- Patients with estimated glomerular filtration rate < 30 mL/min/1.73m²; and patients with incomplete data or missing laboratory values
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 |
|---|---|---|
| No Intervention: Observational CohortThis observational cohort includes female patients undergoing non-cardiac surgery. No intervention was administered as part of the study protocol. Preoperative serum uric acid levels were measured, and patients were followed for the development of postoperative acute kidney injury. Data were analyzed retrospectively to assess the association between uric acid levels and acute kidney injury, with subgroup analyses based on menopausal status (premenopausal vs. postmenopausal women). | Other | Postmenopausal Women, Premenopausal Women |
Primary outcome
Incidence of Postoperative Acute Kidney Injury
Time frame: 7 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No. The dataset used and/or analyzed during the current study is available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uric Acid, run by Asan Medical Center 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: finished, as of the sponsor's last update on 2 Jul 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Acute Kidney Injury (time frame: 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2025.