Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease

Parc de Salut Mar

Status: Active, not recruiting

Conditions: Advanced Chronic Liver Disease; Portal Hypertension Related to Cirrhosis

Treatments: Behavioral: Multidisciplinary support program

Study type: Interventional

Funder types: Other

Identifiers

NCT07249294

HepatoAINEs

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Prevention Strategy

Experimental group

Description:

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.

Treatment:

Behavioral: Multidisciplinary support program