Aminoglycoside ToxicityNCT05533593
Risk Factors and Machine Learning Model for Aminoglycines Related Acute Kidney Injury
An observational study of Aminoglycoside Toxicity and Acute Kidney Injury, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Drug-induced acute kidney injury (D-AKI) can occur after treatment with aminoglycosides. Predicting the risk of D-AKI is important for a tailored prevention and palliation strategy. There are currently no studies to construct a model for predicting the risk of D-AKI associated with aminoglycosides. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aminoglycoside Toxicity, Acute Kidney Injury
- What is being tested?
- Aminoglycoside
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Oct 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were included if received treatment with aminoglycosides and discharged from the hospital between January 1, 2018 and December 31, 2020.
Who may be able to join
- All inpatients who used aminoglycosides during hospitalization
- Hospital stay ≥ 48h
- Age ≥18 years
- There are two or more blood creatinine tests during hospitalization
Who cannot join
- Hospital stay < 48h
- Age <18 years
- Glomerular filtration rate (GFR) < 30ml/min/1.73m2 within 48 hours after admission
- AKI was diagnosed on admission
- Less than two Scr test results during hospitalization
- The Scr values were always lower than 40 μmol/L during hospitalization
- Cases with incomplete medical history information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Risk Factors of Aminoglycines Related Acute Kidney Injury in Hospitalized Patients and Development of Machine Learning Model
Drug-induced acute kidney injury (D-AKI) can occur after treatment with aminoglycosides. Predicting the risk of D-AKI is important for a tailored prevention and palliation strategy. There are currently no studies to construct a model for predicting the risk of D-AKI associated with aminoglycosides. Therefore, the study aimed to develop a model to predict the risk of D-AKI that could be used in clinical practice. Clinical data of inpatients treated with aminoglycosides at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020, were collected. The primary endpoint was D-AKI, defined according to the 2012 Global Outcomes for Kidney Disease Improvement (KDIGO). Patient clinical information, including demographic information, admission and discharge information, disease history, medication information, and laboratory tests, was obtained through an in-hospital electronic medical record system. Independent risk factors associated with D-AKI will be screened by univariate and multifactorial analyses. Covariates with significant differences (P < 0.05) were included in logistic regression models. The models were evaluated by the area under the curve (AUC) of the receiver operating characteristic curve (ROC) obtained by ten-fold cross-validation. Future studies are needed to test the application of this model in clinical practice to determine whether D-AKI in this setting can be predicted and mitigated.
- Conditions
- Aminoglycoside Toxicity, Acute Kidney Injury
- Being tested
- Aminoglycoside
- Keywords
- Aminoglycosides, Acute kidney injury, Pharmacoepidemiology, Miss diagnosis, Risk factors, Logic regression
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminoglycosideDrug
Inpatients using aminoglycoside
| Study group | Role | What they receive |
|---|---|---|
| AKI Group | Not described Receives: Drug: Aminoglycoside | |
| Non-AKI Group | Not described Receives: Drug: Aminoglycoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides
To analyze the incidence of acute kidney injury in hospitalized patients after using aminoglycosides and to build a prediction model.
Measured: Through study completion，up to half a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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 Aminoglycoside ToxicityStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Li，MD, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533593
- Sponsor's protocol ID
- LCYY-LX-20220102
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang P, Chen Q, Lao J, Shi J, Cao J, Li X, Huang X. Machine learning modeling for the risk of acute kidney injury in inpatients receiving amikacin and etimicin. Front Pharmacol. 2025 May 22;16:1538074. doi: 10.3389/fphar.2025.1538074. eCollection 2025.
PubMed 40487395
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors of Aminoglycines Related Acute Kidney Injury in Hospitalized Patients and Development of Machine Learning Model
- ClinicalTrials.gov ID
- NCT05533593
- Acronym / sponsor ID
- LCYY-LX-20220102
- Conditions
- Aminoglycoside Toxicity, Acute Kidney Injury
- Keywords
- Aminoglycosides, Acute kidney injury, Pharmacoepidemiology, Miss diagnosis, Risk factors, Logic regression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 9 Sep 2022 (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.
Drug-induced acute kidney injury (D-AKI) can occur after treatment with aminoglycosides. Predicting the risk of D-AKI is important for a tailored prevention and palliation strategy. There are currently no studies to construct a model for predicting the risk of D-AKI associated with aminoglycosides. Therefore, the study aimed to develop a model to predict the risk of D-AKI that could be used in clinical practice. Clinical data of inpatients treated with aminoglycosides at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020, were collected. The primary endpoint was D-AKI, defined according to the 2012 Global Outcomes for Kidney Disease Improvement (KDIGO). Patient clinical information, including demographic information, admission and discharge information, disease history, medication information, and laboratory tests, was obtained through an in-hospital electronic medical record system. Independent risk factors associated with D-AKI will be screened by univariate and multifactorial analyses. Covariates with significant differences (P < 0.05) were included in logistic regression models. The models were evaluated by the area under the curve (AUC) of the receiver operating characteristic curve (ROC) obtained by ten-fold cross-validation. Future studies are needed to test the application of this model in clinical practice to determine whether D-AKI in this setting can be predicted and mitigated.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI Group | – | Drug: Aminoglycoside |
| Non-AKI Group | – | Drug: Aminoglycoside |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were included if received treatment with aminoglycosides and discharged from the hospital between January 1, 2018 and December 31, 2020.
Key inclusion criteria (4 listed)
- All inpatients who used aminoglycosides during hospitalization
- Hospital stay ≥ 48h
- Age ≥18 years
- There are two or more blood creatinine tests during hospitalization
Key exclusion criteria (7 listed)
- Hospital stay < 48h
- Age <18 years
- Glomerular filtration rate (GFR) < 30ml/min/1.73m2 within 48 hours after admission
- AKI was diagnosed on admission
- Less than two Scr test results during hospitalization
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 |
|---|---|---|
| AminoglycosideInpatients using aminoglycoside | Drug | AKI Group, Non-AKI Group |
Primary outcome
The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides
Time frame: Through study completion，up to half a year.
To analyze the incidence of acute kidney injury in hospitalized patients after using aminoglycosides and to build a prediction model.
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 18 Nov 2023.
- Derived from this study: PubMed 40487395Zhang P, Chen Q, Lao J, Shi J, Cao J, Li X, Huang X. Machine learning modeling for the risk of acute kidney injury in inpatients receiving amikacin and etimicin. Front Pharmacol. 2025 May 22;16:1538074. doi: 10.3389/fphar.2025.1538074. eCollection 2025.
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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 Aminoglycoside Toxicity and Acute Kidney Injury, run by Qianfoshan Hospital at 1 site in China.
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 4 inclusion and 7 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 18 Nov 2023. 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 China. 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?
The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides (time frame: Through study completion，up to half a year.). 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 NCT05533593, 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 18 Nov 2023.