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OpenTrials
Completed

NCT Number: NCT05533619

Risk Factors and Machine Learning Model for Proton Pump Inhibitor Related Acute Kidney Injury

Recent evidence concerns acute kidney injury (AKI) following proton pump inhibitor (PPI) application. Few actual studies have compared the incidence, risk factors, and predictive models of AKI associated with PPI. The present study was a single-center retrospective study. The researchers retrospectively analyzed data from patients who received PPI medications between January 2018 and December 2020. PPI drugs included omeprazole, esomeprazole, rabeprazole, and pantoprazole. The primary outcome of the study was AKI, as defined by kidney disease: improving global outcomes (KDIGO). Secondary outcomes included length of hospital stay, hospital costs, and continuous renal replacement therapy. Independent risk factors associated with AKI were identified by univariate analysis and multifactorial logistic regression analysis (P < 0.05). Logistic regression models were constructed based on the variables obtained from the analysis. Internal validation of the model was performed by the ten-fold cross-validation method. Model discriminatory power was assessed by the area under the curve (AUC) of the receiver operating characteristic curve (ROC). The study aims to develop a PPI-related AKI prediction model based on an electronic medical record system that can be used to predict AKI in hospitalized patients and contribute to the early prevention, diagnosis and treatment of AKI, ultimately reducing morbidity and improving prognosis.

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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 proton pump inhibitor 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

Proton Pump Inhibitor

Drug

Inpatients using proton pump inhibitor

Primary outcomes

  1. The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors

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

    To analyze the incidence of acute kidney injury in hospitalized patients after using proton pump inhibitors, and to build a prediction model. To assess the risk factors before using proton pump inhibitors is helpful to the early prevention, diagnosis and treatment of AKI.

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

Analysis of Risk Factors of Proton Pump Inhibitor Related Acute Kidney Injury in Hospitalized Patients and Developments 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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