NCT01770041

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

January 15, 2013

Last Update Submit

October 15, 2014

Conditions

Liver ResectionParacetamol Administration

Outcome Measures

Primary Outcomes (1)

  • Urinary cysteine

    Post operative days 1-4

Secondary Outcomes (3)

  • mercapturic acid

    post operative days 1-4

  • Glutathione

    day of surgery and post operative days 1 and 3

  • Paracetamol level

    day of surgery and post operative days 1 and 3

Other Outcomes (5)

  • Glucuronamide

    Post-operative days 1-4

  • Sulphate

    Post-operative days 1-4

  • 5-oxoproline

    Post-operative days 1-4

  • +2 more other outcomes

Study Arms (1)

Liver resection group

Patients undergoing liver resection and receiving paracetamol (observation of routine administration)

Other: Paracetamol (observation of routine administration)

Interventions

Paracetamol (observation of routine administration)OTHER

Normal administration of paracetamol as prescribed by operating surgeon

Also known as: Acetaminophen
Liver resection group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients undergoing liver surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Michael J Hughes, MBChB

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

GB(1)