Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT07249294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Program to Avoid NSAIDs in Patients With Advanced Chronic Liver Disease
Sponsor:
Parc de Salut Mar
Organization:
Study Overview
Official Title:
Multidisciplinary Program to Avoid NSAIDs or Metamizole (HepatoAINEs Study) in Patients With Advanced Chronic Liver Disease Undergoing Major Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: