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Clinical Trials/NCT06596798
NCT06596798
Active, not recruiting
Not Applicable

Research on the Risk Warning Model and Prevention Strategies for Acute Kidney Injury Associated With Tacrolimus Based on Explainable Deep Neural Networks and Therapeutic Drug Monitoring

Qianfoshan Hospital1 site in 1 country1,200 target enrollmentSeptember 1, 2024
ConditionsAKI

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
AKI
Sponsor
Qianfoshan Hospital
Enrollment
1200
Locations
1
Primary Endpoint
AKI
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

In this study, the investigators aim to develop a risk prediction model for acute kidney injury (AKI) in hospitalized patients using the calcineurin inhibitor tacrolimus. This will be achieved by mining electronic medical record data and employing explainable deep learning methods. The model will provide clinical decision support for timely intervention and treatment. Compared to traditional machine learning models, deep neural networks can extract more nuanced features from complex medical data and perform more precise pattern recognition, thereby enhancing prediction accuracy and reliability. By constructing a predictive tool based on explainable deep learning models, the investigators will better assess the association between the use of calcineurin inhibitors and AKI, explore targeted prevention strategies, and offer more precise predictions and intervention guidance to clinicians. Additionally, this research has significant socio-economic benefits and application potential. By reducing the incidence of AKI, the investigators can lower patient hospitalization duration and re-treatment costs, conserve medical resources, and improve patient quality of life. Preventive healthcare not only alleviates the physical and psychological burden on patients but also reduces the strain on the healthcare system, enhances healthcare efficiency, and promotes the rational allocation of medical resources.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
December 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Qianfoshan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xiao Li,MD

Associate professor of pharmacy

Qianfoshan Hospital

Eligibility Criteria

Inclusion Criteria

  • Use of tacrolimus during hospitalization, with standardized therapeutic drug monitoring
  • Age of 18 years or older at the time of admission
  • Length of hospital stay ≥ hours
  • At least two serum creatinine level tests conducted during the hospital stay

Exclusion Criteria

  • Stage 5 chronic kidney disease prior to admission
  • Incomplete clinical data
  • Serum creatinine levels consistently below 40 mmol/L during hospitalization

Outcomes

Primary Outcomes

AKI

Time Frame: From January 2020 to December 2023

Acute kidney injury occurred after the patient took tacrolimus during hospitalization

Study Sites (1)

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