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

Overview

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

Full Title of Study: “The Use Of Solid Phase Micro Extraction For Metabolomic Profiling And Concomitant Measurements Of Rocuronium Bromide Levels In Recipients Of Orthotopic Liver Transplantations”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

Interventions

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

Arms, Groups and Cohorts

  • Liver transplant recipient

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Collaborator
    • University of Waterloo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marcin Wasowicz, MD, Principal Investigator, Toronto General Hospital, University Health Network

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.