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OpenTrials
Active, Not Recruiting

NCT Number: NCT06596798

Deep Learning Model and Risk Factors for Tacrolimus-related Acute Kidney Injury

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. AKI

    Time frame: From January 2020 to December 2023

    Acute kidney injury occurred after the patient took tacrolimus during hospitalization

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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