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

Active, not recruiting

• Conditions: AKI; Therapeutic Drug Monitoring (TDM)

• Registration Number: NCT06596811
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

In this study, the investigators will focus on hospitalized patients using cyclosporine and develop an acute kidney injury risk prediction model through in-depth analysis of electronic medical record data, employing interpretable deep learning methods. This model aims to provide timely decision-making support for clinicians regarding prevention and treatment. Compared to traditional machine learning models, deep neural network models can extract deeper features from complex medical data and perform more precise pattern recognition, thereby improving the accuracy and reliability of predictions. By developing a prediction tool based on interpretable deep learning models, the investigators will be able to better assess the association between the use of CNI-class immunosuppressants and acute kidney injury, explore targeted prevention strategies, and offer more accurate prediction and intervention guidance for clinicians. Additionally, this study has significant socioeconomic benefits and promising prospects for application and promotion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2024-09-08
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. During hospitalization, tacrolimus or cyclosporine was used, and therapeutic drug monitoring was conducted according to standard procedures.
2. Aged 18 years or older at the time of admission.
3. Length of hospital stay > 48 hours.
4. At least 2 serum creatinine tests were conducted during hospitalization.

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Exclusion Criteria

1. Chronic kidney disease stage 5 was achieved before admission.
2. Incomplete clinical data.
3. Serum creatinine levels were consistently below 40 mmol/L during hospitalization.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AKI	From January 2020 to December 2023	Acute kidney injury occurred in hospitalized patients treated with cyclosporine

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, China