Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease

NCT07249294 | Active Not Recruiting DMC

• 1 other identifier: HepatoAINEs
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Chronic Liver Disease; Portal Hypertension Related to Cirrhosis

Keywords

Multidisciplinary; Advanced Chronic Liver Disease; Surgery; NSAIDs; Metamizole

Outcome Measures

Primary Outcomes (1)

• NSAIDs/metamizole prescription

  rate of NSAIDs/metamizole prescriptions in patients with ACLD after surgery

  180 days

Secondary Outcomes (1)

• complications

  180 days

Study Arms (1)

Prevention Strategy

EXPERIMENTAL

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

Interventions

Multidisciplinary support program 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.

Prevention Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>18 years) with ACLD scheduled for major surgery

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (1)

• 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.

  PMID: 36676081 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD. PhD.

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

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)