Paracetamol Metabolism After Liver Surgery

Completed

• Conditions: Liver Resection; Paracetamol Administration
• Interventions: Other: Paracetamol (observation of routine administration)

• Registration Number: NCT01770041
• Lead Sponsor: University of Edinburgh

Brief Summary

This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.

Detailed Description

Paracetamol is normally metabolised by the glucuronidation and sulfation of paracetamol to non toxic end products. If paracetamol is administered in supra-therapeutic doses this pathway becomes saturated and an alternative pathway is utilised. This results in a toxic metabolite called N-acetyl-p-benzoquinone imine (NAPQI). If NAPQI is not metabolised by glutathione to cysteine and mercapturic acid, then NAPQI bind to hepatic cells resulting in necrosis and hepatotoxicity.

Therefore the investigators plan to measure the levels of the paracetamol metabolites in patient undergoing liver resection.

Patients will undergo liver resection according to their onco-surgical requirements. As part of the normal post operative care they will receive 1g paracetamol every six hours unless stated otherwise by the operating surgeon. Urinary samples will be taken for the first 4 post operative days and used for analysis of the urinary paracetamol metabolite levels.

Study Timeline

• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Study Start: 2013-02
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients undergoing liver surgery

Exclusion Criteria

• Contra-indication to paracetamol
• Inability to give written, informed consent.
• Jaundice (Bilirubin > 100 μmol/L).
• Liver resection combined with secondary surgical procedure.
• Age < 18 years.
• Pregnant women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver resection group	Paracetamol (observation of routine administration)	Patients undergoing liver resection and receiving paracetamol (observation of routine administration)

Primary Outcome Measures

Name	Time	Method
Urinary cysteine	Post operative days 1-4

Secondary Outcome Measures

Name	Time	Method
mercapturic acid	post operative days 1-4
Glutathione	day of surgery and post operative days 1 and 3
Paracetamol level	day of surgery and post operative days 1 and 3

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Lothian, United Kingdom