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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533593
• Other study ID #: LCYY-LX-20220102
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Drug:
• Aminoglycoside
Inpatients using aminoglycoside

Locations

Country	Name	City	State
China	Xiao Li,MD	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion,up to half a year.