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Completed

NCT Number: NCT01770041

Paracetamol Metabolism After Liver Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paracetamol (observation of routine administration)

Other

Normal administration of paracetamol as prescribed by operating surgeon

Other names: Acetaminophen

Primary outcomes

  1. Urinary cysteine

    Time frame: Post operative days 1-4

Secondary outcomes

  1. mercapturic acid

    Time frame: post operative days 1-4

  2. Glutathione

    Time frame: day of surgery and post operative days 1 and 3

  3. Paracetamol level

    Time frame: day of surgery and post operative days 1 and 3

Other outcomes

  1. Glucuronamide

    Time frame: Post-operative days 1-4

  2. Sulphate

    Time frame: Post-operative days 1-4

  3. 5-oxoproline

    Time frame: Post-operative days 1-4

  4. Complications

    Time frame: Day of surgery and post-operative days 1-30

  5. Post-operative blood tests (FBC, U&E, LFTs, Coag)

    Time frame: Post-operative dyas 1-7

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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

Acronym: PETALS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 17, 2013
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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