Risk Factors and Machine Learning Model for Aminoglycines Related Acute Kidney Injury

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05533593

Collaborator

(none)

8,000

Enrollment

Location

Anticipated Duration (Months)

333.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Aminoglycoside Toxicity Acute Kidney Injury	Drug: Aminoglycoside

Study Design

Study Type:

Observational

Anticipated Enrollment :

8000 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
AKI Group	Drug: Aminoglycoside Inpatients using aminoglycoside
Non-AKI Group	Drug: Aminoglycoside Inpatients using aminoglycoside

Arm

Intervention/Treatment

AKI Group

Drug: Aminoglycoside

Inpatients using aminoglycoside

Non-AKI Group

Drug: Aminoglycoside

Inpatients using aminoglycoside

Outcome Measures

Primary Outcome Measures

The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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