Proton Pump Inhibitors in Cirrhotic Patients

NCT06384443 | Completed

• 1 other identifier: 01001099646
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Proton Pump Inhibitor Adverse Reaction; Liver Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Inappropriate use of PPI

PPI is prescribed without approved indication or used for a prolonged period beyond the recommended duration.

Appropriate use of PPI

PPI is prescribed for the approved indication and used within the recommended duration.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a histological, biochemical, imaging and/or clinical data of cirrhosis

You may qualify if:

• Patients receiving proton pump inhibitors at the time of enrollment.

You may not qualify if:

• Refusal to sign the informed consent form or failure to provide the required information

Sponsors & Collaborators

• National Liver Institute, Egypt: lead

Study Sites (1)

National Liver institute - Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related Publications (1)

• El-Azab G, Zakareya T, Abdel Aleem M, Edrees A. Inappropriate use of proton pump inhibitors in patients with liver cirrhosis: a cross-sectional study. Eur J Gastroenterol Hepatol. 2025 Oct 1;37(10):1141-1146. doi: 10.1097/MEG.0000000000002985. Epub 2025 Apr 29.

  PMID: 40359285 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Encephalopathy; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gasser I El-Azab, M.D.

  National Liver Institute, Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: October 1, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)