ClinicalTrials.gov
ClinicalTrials.gov Menu

Paracetamol Metabolism After Liver Surgery (PETALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01770041
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : October 16, 2014
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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

Condition or disease Intervention/treatment
Liver Resection Paracetamol Administration Other: Paracetamol (observation of routine administration)

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
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.
Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Acetaminophen



Primary Outcome Measures :
  1. Urinary cysteine [ Time Frame: Post operative days 1-4 ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]

Biospecimen Retention:   Samples Without DNA
Urine and blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770041


Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Michael J Hughes, MBChB University of Edinburgh

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01770041     History of Changes
Other Study ID Numbers: 12/SS/0222
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics