- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770041
Paracetamol Metabolism After Liver Surgery (PETALS)
Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lothian
-
Edinburgh, Lothian, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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)
|
Normal administration of paracetamol as prescribed by operating surgeon
Other Names:
|
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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