Clinical trial

Analysis of Risk Factors of Aminoglycines Related Acute Kidney Injury in Hospitalized Patients and Development of Machine Learning Model

Name
LCYY-LX-20220102
Description
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.
Trial arms
Trial start
2022-07-01
Estimated PCD
2023-10-31
Trial end
2023-10-31
Status
Completed
Treatment
Aminoglycoside
Inpatients using aminoglycoside
Arms:
AKI Group, Non-AKI Group
Size
8000
Primary endpoint
The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides
Through study completion,up to half a year.
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 8000, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

1 product

2 indications