Paracetamol Metabolism After Liver Surgery

NCT ID: NCT01770041

Last Updated: 2014-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Resection Paracetamol Administration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver resection group

Patients undergoing liver resection and receiving paracetamol (observation of routine administration)

Paracetamol (observation of routine administration)

Intervention Type OTHER

Normal administration of paracetamol as prescribed by operating surgeon

Interventions

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Paracetamol (observation of routine administration)

Normal administration of paracetamol as prescribed by operating surgeon

Intervention Type OTHER

Other Intervention Names

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Acetaminophen

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Hughes, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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12/SS/0222

Identifier Type: -

Identifier Source: org_study_id

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