Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease

NCT ID: NCT07249294

Last Updated: 2025-12-03

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Advanced Chronic Liver Disease Portal Hypertension Related to Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Prospective interventional study with single-group assignment. A historical cohort will be used for external comparison but is not part of the randomized arms.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Multidisciplinary support program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults (\>18 years) with ACLD scheduled for major surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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José Antonio Carrion

Prof. MD. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Canillas L, Pelegrina A, Alvarez J, Colominas-Gonzalez E, Salar A, Aguilera L, Burdio F, Montes A, Grau S, Grande L, Carrion JA. Clinical Guideline on Perioperative Management of Patients with Advanced Chronic Liver Disease. Life (Basel). 2023 Jan 3;13(1):132. doi: 10.3390/life13010132.

Reference Type BACKGROUND
PMID: 36676081 (View on PubMed)

Other Identifiers

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HepatoAINEs

Identifier Type: -

Identifier Source: org_study_id

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