Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07249294

Enrollment

Registered

2025-11-25

Start date

2023-04-01

Completion date

2026-06-30

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Chronic Liver Disease, Portal Hypertension Related to Cirrhosis

Keywords

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

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.

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.

Interventions

BEHAVIORALMultidisciplinary 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Absence of ACLD or portal hypertension, lack of informed consent

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026