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Paracetamol Metabolism After Liver Surgery

Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01770041
Acronym
PETALS
Enrollment
42
Registered
2013-01-17
Start date
2013-02-28
Completion date
2014-06-30
Last updated
2014-10-16

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

Conditions

Liver Resection, Paracetamol Administration

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.

Interventions

OTHERParacetamol (observation of routine administration)

Normal administration of paracetamol as prescribed by operating surgeon

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Urinary cysteinePost operative days 1-4

Secondary

MeasureTime frame
mercapturic acidpost operative days 1-4
Glutathioneday of surgery and post operative days 1 and 3
Paracetamol levelday of surgery and post operative days 1 and 3

Other

MeasureTime frame
GlucuronamidePost-operative days 1-4
Post-operative blood tests (FBC, U&E, LFTs, Coag)Post-operative dyas 1-7
SulphatePost-operative days 1-4
5-oxoprolinePost-operative days 1-4
ComplicationsDay of surgery and post-operative days 1-30

Countries

United Kingdom

Outcome results

None listed

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