Proton Pump Inhibitors in Cirrhotic Patients

NCT ID: NCT06384443

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-03-01

Brief Summary

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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

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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.

Conditions

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Proton Pump Inhibitor Adverse Reaction Liver Cirrhosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Inappropriate use of PPI

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

No interventions assigned to this group

Appropriate use of PPI

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Liver Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gasser I El-Azab, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Liver Institute, Menoufia University

Locations

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National Liver institute - Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 40359285 (View on PubMed)

Other Identifiers

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01001099646

Identifier Type: -

Identifier Source: org_study_id

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