Risk Factors and Machine Learning Model for Proton Pump I... | NCT05533619

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

NCT05533619

Sponsor

Qianfoshan Hospital

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

30,000Actual

Phase

Not provided

Conditions

Proton Pump Inhibitor
Acute Kidney Injury

Interventions

Proton pump inhibitor

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 31, 2023Actual

First Submitted Date

Sep 2, 2022

First Submission Date that Met QC Criteria

Sep 8, 2022

First Posted Date

Sep 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao Li，MD, Associate professor of pharmacy, Qianfoshan HospitalPrincipal Investigator

Lead Sponsor

Qianfoshan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AKI Group			Drug: Proton pump inhibitor
Non-AKI Group			Drug: Proton pump inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proton pump inhibitor	Drug	Inpatients using proton pump inhibitor	AKI Group Non-AKI Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiao Li，MD		Jinan	Shandong	250014	China

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054328	Proton Pump Inhibitors

Ancestor Terms

ID	Term
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided