Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease

November 25, 2025 updated by: José Antonio Carrion, Parc de Salut Mar

Multidisciplinary Program to Avoid NSAIDs or Metamizole (HepatoAINEs Study) in Patients With Advanced Chronic Liver Disease Undergoing Major Surgery

This study aims to implement measures to avoid the use of NSAIDs or metamizole in patients with advanced chronic liver disease (ACLD) scheduled for major surgery, which are contraindicated due to increased risk of renal dysfunction such as acute kidney injury (AKI), clinical decompensation such as ascites, and bleeding.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The "HepatoAINEs" program introduces information and communication technologies (ICTs) to identify patients with ACLD and prevent NSAIDs/metamizole prescription during perioperative care. The intervention includes guideline updates, automated alerts, and multidisciplinary support program (MSP) with collaboration among Digestive, Anesthesia, Surgery, and Pharmacy services to avoid the use of NSAIDs or metamizole in patients with ACLD scheduled for major surgery.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (>18 years) with ACLD scheduled for major surgery
  • Exclusion Criteria: Absence of ACLD or portal hypertension, lack of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevention Strategy
Participants with cirrhosis will receive an intervention designed to prevent the administration of non-steroidal anti-inflammatory drugs (NSAIDs), which are contraindicated in this population. The intervention includes clinical alerts, prescriber education, and pharmacy verification steps. Outcomes will be compared to a historical cohort of cirrhotic patients who were exposed to NSAIDs prior to implementation of the preventive strategy.
Behavioral: Multidisciplinary support program
The intervention includes guideline updates, automated alerts, and multidisciplinary support program (MSP) with collaboration among Digestive, Anesthesia, Surgery, and Pharmacy services to avoid the use of NSAIDs or metamizole in patients with cirrhosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NSAIDs/metamizole prescription
Time Frame: 180 days
rate of NSAIDs/metamizole prescriptions in patients with ACLD after surgery
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 180 days
rate of AKI, ascites, bleeding, and mortality in patients with ACLD after surgery
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HepatoAINEs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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