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Completed

NCT Number: NCT05533593

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiao Li,MD

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Aminoglycoside

Drug

Inpatients using aminoglycoside

Primary outcomes

  1. The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides

    Time frame: Through study completion,up to half a year.

    To analyze the incidence of acute kidney injury in hospitalized patients after using aminoglycosides and to build a prediction model.

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2022
Registry last updated
Nov 18, 2023

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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