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The Use Of Solid Phase Micro-extraction (SPME) For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation

This study is currently recruiting participants.
Verified February 2013 by University Health Network, Toronto
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01404793
First received: July 26, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Liver Failure
 Drug: Rocuronium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use Of Solid Phase Micro Extraction For Metabolomic Profiling And Concomitant Measurements Of Rocuronium Bromide Levels In Recipients Of Orthotopic Liver Transplantations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Plasma drug and drug metabolite concentrations [ Time Frame: 5, 30, 60, 90, 120, 180, 240, 300, 450 mins ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liver transplant recipient Drug: Rocuronium
After insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered
Other Names:
  • Zemuron
  • Esmeron

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving liver transplants at University Health Network, Toronto General Hospital.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404793

Contacts
Contact: Marcin Wasowicz, MD 416-340-4800 ext 3350 marcin.wasowicz@uhn.on.ca
Contact: Jo Carroll 416-340-4800 ext 3243 jo.carroll@uhn.on.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada
Principal Investigator: Marcin Wasowicz, MD            
Sub-Investigator: Stuart McCluskey, MD            
Sub-Investigator: Angela Jerath, MD            
Sponsors and Collaborators
University Health Network, Toronto
University of Waterloo
Investigators
Principal Investigator: Marcin Wasowicz, MD Toronto General Hospital, University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01404793     History of Changes
Other Study ID Numbers: UHN REB 11-0325-BE
Study First Received: July 26, 2011
Last Updated: February 20, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Liver Transplantation
Solid Phase Micro Extraction
Rocuronium
 Metabolomics
Pharmacokinetics
Clinical Marker

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Rocuronium
Neuromuscular Nondepolarizing Agents
 Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013