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Active, Not Recruiting

NCT Number: NCT07249294

Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Chronic Liver Disease Portal Hypertension Related to Cirrhosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. NSAIDs/metamizole prescription

    Time frame: 180 days

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

Secondary outcomes

  1. complications

    Time frame: 180 days

    rate of AKI, ascites, bleeding, and mortality in patients with ACLD after surgery

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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