Proton Pump InhibitorNCT05533619
Risk Factors and Machine Learning Model for Proton Pump Inhibitor Related Acute Kidney Injury
An observational study of Proton Pump Inhibitor and Acute Kidney Injury, run by Qianfoshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Proton Pump Inhibitor, Acute Kidney Injury
- What is being tested?
- Proton pump inhibitor
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Risk Factors of Proton Pump Inhibitor Related Acute Kidney Injury in Hospitalized Patients and Developments of Machine Learning Model
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
- Being tested
- Proton pump inhibitor
- Keywords
- Proton pump inhibitor, Acute kidney injury, Pharmacoepidemiology, Miss diagnosis, Risk factors, Logic regression
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton pump inhibitorDrug
Inpatients using proton pump inhibitor
| Study group | Role | What they receive |
|---|---|---|
| AKI Group | Not described Receives: Drug: Proton pump inhibitor | |
| Non-AKI Group | Not described Receives: Drug: Proton pump inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion，up to half a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton Pump InhibitorStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Li，MD, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533619
- Sponsor's protocol ID
- LCYY-LX-20220104
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors of Proton Pump Inhibitor Related Acute Kidney Injury in Hospitalized Patients and Developments of Machine Learning Model
- ClinicalTrials.gov ID
- NCT05533619
- Acronym / sponsor ID
- LCYY-LX-20220104
- Conditions
- Proton Pump Inhibitor, Acute Kidney Injury
- Keywords
- Proton pump inhibitor, Acute kidney injury, Pharmacoepidemiology, Miss diagnosis, Risk factors, Logic regression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI Group | – | Drug: Proton pump inhibitor |
| Non-AKI Group | – | Drug: Proton pump inhibitor |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton pump inhibitorInpatients using proton pump inhibitor | Drug | AKI Group, Non-AKI Group |
Primary outcome
The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors
Time frame: Through study completion，up to half a year.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proton Pump Inhibitor and Acute Kidney Injury, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors (time frame: Through study completion，up to half a year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 3 Nov 2026.