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

NCT01404793 | Completed

• 1 other identifier: UHN REB 11-0325-BE
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

Liver Transplantation; Solid Phase Micro Extraction; Rocuronium; Metabolomics; Pharmacokinetics; Clinical Marker

Outcome Measures

Primary Outcomes (1)

• Plasma drug and drug metabolite concentrations

  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

Study Arms (1)

Liver transplant recipient

Drug: Rocuronium

Interventions

Rocuronium DRUG

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

Also known as: Zemuron, Esmeron

Liver transplant recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• First time liver transplant recipients above 18 years of age
• Elective cadaveric or living donor liver transplant patients will be recruited

You may not qualify if:

• All patients under 18 years of age
• Unable to give consent

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Waterloo: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Liver Failure

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Marcin Wasowicz, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 28, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

CA (1)