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

Completed

• Conditions: Liver Failure
• Interventions: Drug: Rocuronium

• Registration Number: NCT01404793
• Lead Sponsor: University Health Network, Toronto

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Start: 2011-09
• Primary Completion: 2014-04
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver transplant recipient	Rocuronium	-

Primary Outcome Measures

Name	Time	Method
Plasma drug and drug metabolite concentrations	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.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada