Trial record 5 of 13 for:    ACETAMINOPHEN METABOLISM

Paracetamol Metabolism After Liver Surgery (PETALS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Edinburgh
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01770041
First received: January 15, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Liver Resection
Paracetamol Administration
Other: Paracetamol (observation of routine administration)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Urinary cysteine [ Time Frame: Post operative days 1-4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Glucuronamide [ Time Frame: Post-operative days 1-4 ] [ Designated as safety issue: No ]
  • Sulphate [ Time Frame: Post-operative days 1-4 ] [ Designated as safety issue: No ]
  • 5-oxoproline [ Time Frame: Post-operative days 1-4 ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: Day of surgery and post-operative days 1-30 ] [ Designated as safety issue: No ]
  • Post-operative blood tests (FBC, U&E, LFTs, Coag) [ Time Frame: Post-operative dyas 1-7 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine and blood


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770041

Contacts
Contact: Michael J Hughes, MBChB +44 131 242 3631 ext 23631 michaelh@doctors.net.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SA
Contact: Michael J Hughes, MBChB    +44 131 242 3631 ext 23631    michaelh@doctors.net.uk   
Principal Investigator: Michael J Hughes, MBChB         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Michael J Hughes, MBChB University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01770041     History of Changes
Other Study ID Numbers: 12/SS/0222
Study First Received: January 15, 2013
Last Updated: May 21, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 29, 2014