Paracetamol Metabolism After Liver Surgery (PETALS)

October 15, 2014 updated by: University of Edinburgh

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with benign or malignant liver tumours that have been deemed by the hepatobiliary multi-disciplinary team meetiong as requiring surgical intervention.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver resection group
Patients undergoing liver resection and receiving paracetamol (observation of routine administration)
Other: Paracetamol (observation of routine administration)
Normal administration of paracetamol as prescribed by operating surgeon
Other Names:
  • Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary cysteine
Time Frame: Post operative days 1-4
Post operative days 1-4

Secondary Outcome Measures

Outcome Measure
Time Frame
mercapturic acid
Time Frame: post operative days 1-4
post operative days 1-4
Glutathione
Time Frame: day of surgery and post operative days 1 and 3
day of surgery and post operative days 1 and 3
Paracetamol level
Time Frame: day of surgery and post operative days 1 and 3
day of surgery and post operative days 1 and 3

Other Outcome Measures

Outcome Measure
Time Frame
Glucuronamide
Time Frame: Post-operative days 1-4
Post-operative days 1-4
Sulphate
Time Frame: Post-operative days 1-4
Post-operative days 1-4
5-oxoproline
Time Frame: Post-operative days 1-4
Post-operative days 1-4
Complications
Time Frame: Day of surgery and post-operative days 1-30
Day of surgery and post-operative days 1-30
Post-operative blood tests (FBC, U&E, LFTs, Coag)
Time Frame: Post-operative dyas 1-7
Post-operative dyas 1-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/SS/0222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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