Proton Pump Inhibitors in Cirrhotic Patients

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.

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Key information

Conditions

Proton Pump Inhibitor Adverse Reaction Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Hypertension, Portal Liver Cirrhosis Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Liver institute - Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Inappropriate use of PPIs

Time frame: Six weeks after study completion

Explore 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 PPIs

Time frame: Eight weeks after study completion

Determine independent predictors of inappropriate use of PPIs in patients with liver cirrhosis using multivariate analyses.

Sponsors and collaborators

Lead sponsor

National Liver Institute, Egypt

Other

Registry information

Official study title

Inappropriate Use of Proton Pump Inhibitors in Patients With Liver Cirrhosis

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Apr 25, 2024
Registry last updated: Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed