Paracetamol Metabolism After Liver Surgery (PETALS)
This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.|
- Urinary cysteine [ Time Frame: Post operative days 1-4 ] [ Designated as safety issue: No ]
- mercapturic acid [ Time Frame: post operative days 1-4 ] [ Designated as safety issue: No ]
- Glutathione [ Time Frame: day of surgery and post operative days 1 and 3 ] [ Designated as safety issue: No ]
- Paracetamol level [ Time Frame: day of surgery and post operative days 1 and 3 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Urine and blood
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Liver resection group
Patients undergoing liver resection
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.
|Contact: Michael J Hughes, MBChB||+44 131 242 3631 ext email@example.com|
|Royal Infirmary of Edinburgh||Recruiting|
|Edinburgh, Lothian, United Kingdom, EH16 4SA|
|Contact: Michael J Hughes, MBChB +44 131 242 3631 ext 23631 firstname.lastname@example.org|
|Principal Investigator: Michael J Hughes, MBChB|
|Principal Investigator:||Michael J Hughes, MBChB||University of Edinburgh|