SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation

NCT ID: NCT01404793

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-04-30

Brief Summary

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

Conditions

Liver Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Liver transplant recipient

Rocuronium

Intervention Type: DRUG

After insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered

Interventions

Rocuronium

After insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered

Intervention Type: DRUG

Other Intervention Names

Zemuron; Esmeron

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Waterloo

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcin Wasowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 11-0325-BE

Identifier Type: -

Identifier Source: org_study_id