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NCT06384443 Clinical Trial

Proton Pump Inhibitors in Cirrhotic Patients

Liver Cirrhosis Clinical Trial

Official title:
Inappropriate Use of Proton Pump Inhibitors in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06384443
Other study ID # 01001099646
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date March 1, 2024

Study information
Verified date April 2024
Source National Liver Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors.

Description:

The inappropriate use of PPIs in cirrhosis patients is a growing concern. Evidence supporting the use of PPIs in cirrhosis-related conditions is limited. Several adverse outcomes have been linked to PPI use in cirrhosis, including an increased risk of spontaneous bacterial peritonitis and hepatic encephalopathy. The study aimed to assess the appropriateness of prescribing PPIs to patients with cirrhosis, examining its impact on prescribing practices and identifying associated factors. in this observational, descriptive, cross-sectional study, cirrhotic patients receiving proton pump inhibitors will be included in the study. Enrolled patients will classified according to the indication for PPI administration: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. Use of PPI will be considered inappropriate when prescribed without approved indication or used for a prolonged period beyond the recommended duration. The prevalence of PPI misuse in cirrhotics will be estimated and multivariate analyses will be conducted in order to identify independent predictors of inappropriate use of PPI.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients receiving proton pump inhibitors at the time of enrollment. Exclusion Criteria: - Refusal to sign the informed consent form or failure to provide the required information

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt National Liver institute - Menoufia University Shibin Al Kawm Menoufia

Sponsors (1)
Lead Sponsor Collaborator
National Liver Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inappropriate use of PPIs Explore the prevalence of using PPIs without approved indication or for a prolonged period beyond the recommended duration in patients with liver cirrhosis Six weeks after study completion
Primary Predictors for inappropriate use of PPIs Determine independent predictors of inappropriate use of PPIs in patients with liver cirrhosis using multivariate analyses. Eight weeks after study completion
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