Clinical trial

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

Name
LCYY-LX-20220104
Description
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.
Trial arms
Trial start
2022-07-01
Estimated PCD
2023-10-31
Trial end
2023-10-31
Status
Completed
Treatment
Proton pump inhibitor
Inpatients using proton pump inhibitor
Arms:
AKI Group, Non-AKI Group
Size
30000
Primary endpoint
The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors
Through study completion,up to half a year.
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 30000, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

1 product

2 indications

Indication
PPI