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

NCT ID: NCT05533619

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-10-31

Brief Summary

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.

Conditions

Proton Pump Inhibitor; Acute Kidney Injury

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

AKI Group

Proton pump inhibitor

Intervention Type: DRUG

Inpatients using proton pump inhibitor

Non-AKI Group

Proton pump inhibitor

Intervention Type: DRUG

Inpatients using proton pump inhibitor

Interventions

Proton pump inhibitor

Inpatients using proton pump inhibitor

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Li，MD

Associate professor of pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiao Li，MD

Jinan, Shandong, China

Countries

China

Other Identifiers

LCYY-LX-20220104

Identifier Type: -

Identifier Source: org_study_id