Clinical trial NCT05533619: Risk Factors and Machine Learning Model for Proton Pump Inhibitor Related Acute Kidney Injury
Official title: Analysis of Risk Factors of Proton Pump Inhibitor Related Acute Kidney Injury in Hospitalized Patients and Developments of Machine Learning Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proton Pump Inhibitor
Acute Kidney Injury
Keywords: Proton pump inhibitor
Acute kidney injury
Pharmacoepidemiology
Miss diagnosis
Risk factors
Logic regression
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were included if received treatment with proton pump inhibitor and discharged from the hospital between January 1, 2018 and December 31, 2020

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.


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

Primary outcomes:
measure: The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors
timeFrame: Through study completion，up to half a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Xiao Li，MD
state: Shandong
Study officials:
References: