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

NCT06596798 | Active Not Recruiting

• 1 other identifier: LCYX-LX-20240102
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

AKI

Keywords

Acute kidney injury; Therapeutic Drug Monitoring; deep learning

Outcome Measures

Primary Outcomes (1)

• AKI

  Acute kidney injury occurred after the patient took tacrolimus during hospitalization

  From January 2020 to December 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project is a multicenter study involving hospitalized patients who received tacrolimus treatment and underwent therapeutic drug monitoring at three medical centers from January 2020 to December 2023: Shandong University First Affiliated Hospital, Binzhou Medical University Affiliated Hospital, and Jinan First People\'s Hospital. The diagnosis and staging of acute kidney injury (AKI) in this study follow the relevant diagnostic criteria outlined in the 2012 KDIGO Clinical Practice Guidelines for AKI. AKI is defined by meeting at least one of the following conditions: (1) an increase in serum creatinine (SCr) \> 26.5 mmol/L (\>0.3 mg/dL) within 48 hours, or an increase in SCr to \>1.5 to 1.9 times the baseline value within a continuous 7-day period; (2) a urine output of \<0.5 mL/(kg·h) for 6 to 12 hours.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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

Jinan, Shandong, 250014, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Demographic data, vital signs, laboratory examination, admission diagnosis, comorbidities, medication history, medical history, blood drug concentration

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Xiao Lii

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)