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

NCT01404793 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2015-04-24

No results posted yet for this study

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

Interventions

DRUG

Rocuronium

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

Sponsors & Collaborators

  • University of Waterloo

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Marcin Wasowicz, MD · Toronto General Hospital, University Health Network

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-04-30
Completion
2015-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404793 on ClinicalTrials.gov