- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01404793
SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation
April 23, 2015 updated by: University Health Network, Toronto
The Use Of Solid Phase Micro Extraction For Metabolomic Profiling And Concomitant Measurements Of Rocuronium Bromide Levels In Recipients Of Orthotopic Liver Transplantations
Standard anesthetic management of liver transplantation patients includes a general anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium.
Pharmacokinetic modelling of this agent has been poorly described during liver transplantation, which impacts on appropriate dosing of this agent within this population where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during the various phases of liver transplantation.
Plasma drug and drug metabolite concentrations will be measured using the technique of solid phase micro-extraction (SPME).
Measuring and correlating the levels of rocuronium and other liver metabolites with the degree of post transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity
Study Overview
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
-
Toronto, Ontario, Canada
- Toronto General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients receiving liver transplants at University Health Network, Toronto General Hospital.
Description
Inclusion Criteria:
- First time liver transplant recipients above 18 years of age
- Elective cadaveric or living donor liver transplant patients will be recruited
Exclusion Criteria:
- All patients under 18 years of age
- Unable to give consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Liver transplant recipient
|
After insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma drug and drug metabolite concentrations
Time Frame: 5, 30, 60, 90, 120, 180, 240, 300, 450 mins
|
All liver transplant recipients in this study will receive standard level of care including general anesthesia and the use of invasive arterial and central line monitoring.
On induction, patients will receive the neuromuscular relaxant cisatracurium at 0.1 mg kg-1.
After insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered.
If further muscle relaxation is required, cistaracurium will be administered.
Collection of 5ml blood samples will be performed at: 5, 30, 60, 90, 120, 180, 240, 300, 450 mins post bolus administration.
|
5, 30, 60, 90, 120, 180, 240, 300, 450 mins
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
July 27, 2011
First Posted (Estimate)
July 28, 2011
Study Record Updates
Last Update Posted (Estimate)
April 24, 2015
Last Update Submitted That Met QC Criteria
April 23, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 11-0325-BE
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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