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

NCT05533619 | Completed

• 1 other identifier: LCYY-LX-20220104
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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

Keywords

Proton pump inhibitor; Acute kidney injury; Pharmacoepidemiology; Miss diagnosis; Risk factors; Logic regression

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

AKI Group

Drug: Proton pump inhibitor

Non-AKI Group

Drug: Proton pump inhibitor

Interventions

Proton pump inhibitor DRUG

Inpatients using proton pump inhibitor

AKI Group; Non-AKI Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Xiao Li，MD

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 9, 2022
• Study Start: July 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)