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Proton Pump Inhibitors in Cirrhotic Patients

Inappropriate Use of Proton Pump Inhibitors in Patients With Liver Cirrhosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06384443
Enrollment
1000
Registered
2024-04-25
Start date
2020-10-01
Completion date
2024-03-01
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Proton Pump Inhibitor Adverse Reaction

Keywords

Proton pump inhibitors, liver cirrhosis, spontaneous bacterial peritonitis, hepatic encephalopathy, portal hypertension

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

National Liver Institute, Egypt
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Inappropriate use of PPIsSix weeks after study completionExplore the prevalence of using PPIs without approved indication or for a prolonged period beyond the recommended duration in patients with liver cirrhosis
Predictors for inappropriate use of PPIsEight weeks after study completionDetermine independent predictors of inappropriate use of PPIs in patients with liver cirrhosis using multivariate analyses.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026