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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533619
• Other study ID #: LCYY-LX-20220104
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30000
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Proton Pump Inhibitor
• Wounds and Injuries

Intervention

Drug:
• Proton pump inhibitor
Inpatients using proton pump inhibitor

Locations

Country	Name	City	State
China	Xiao Li,MD	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors	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.	Through study completion,up to half a year.