- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05533593
Risk Factors and Machine Learning Model for Aminoglycines Related Acute Kidney Injury
November 15, 2023 updated by: Xiao Li,MD, Qianfoshan Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
8000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
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Jinan, Shandong, China, 250014
- Xiao Li,MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The patients were included if received treatment with aminoglycosides and discharged from the hospital between January 1, 2018 and December 31, 2020.
Description
Inclusion Criteria:
- All inpatients who used aminoglycosides during hospitalization
- Hospital stay ≥ 48h
- Age ≥18 years
- There are two or more blood creatinine tests during hospitalization
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AKI Group
|
Inpatients using aminoglycoside
|
Non-AKI Group
|
Inpatients using aminoglycoside
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion,up to half a year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
September 2, 2022
First Submitted That Met QC Criteria
September 8, 2022
First Posted (Actual)
September 9, 2022
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCYY-LX-20220102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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