Liver FailureNCT01404793
SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation
An observational study of Liver Failure, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure
- What is being tested?
- Rocuronium
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving liver transplants at University Health Network, Toronto General Hospital.
Who may be able to join
- First time liver transplant recipients above 18 years of age
- Elective cadaveric or living donor liver transplant patients will be recruited
Who cannot join
- All patients under 18 years of age
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use Of Solid Phase Micro Extraction For Metabolomic Profiling And Concomitant Measurements Of Rocuronium Bromide Levels In Recipients Of Orthotopic Liver Transplantations
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
- Being tested
- Rocuronium
- Keywords
- Liver Transplantation, Solid Phase Micro Extraction, Rocuronium, Metabolomics, Pharmacokinetics, Clinical Marker
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Zemuron, Esmeron
After insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant recipient | Not described Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5, 30, 60, 90, 120, 180, 240, 300, 450 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
- Investigators
- Marcin Wasowicz, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404793
- Sponsor's protocol ID
- UHN REB 11-0325-BE
- Status last verified
- Apr 2015
- First submitted
- 26 Jul 2011
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of Solid Phase Micro Extraction For Metabolomic Profiling And Concomitant Measurements Of Rocuronium Bromide Levels In Recipients Of Orthotopic Liver Transplantations
- ClinicalTrials.gov ID
- NCT01404793
- Acronym / sponsor ID
- UHN REB 11-0325-BE
- Conditions
- Liver Failure
- Keywords
- Liver Transplantation, Solid Phase Micro Extraction, Rocuronium, Metabolomics, Pharmacokinetics, Clinical Marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Waterloo
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant recipient | – | Drug: Rocuronium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving liver transplants at University Health Network, Toronto General Hospital.
Key inclusion criteria (2 listed)
- First time liver transplant recipients above 18 years of age
- Elective cadaveric or living donor liver transplant patients will be recruited
Key exclusion criteria (2 listed)
- All patients under 18 years of age
- Unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocuroniumAlso: Zemuron, EsmeronAfter insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered | Drug | Liver transplant recipient |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
Related trials for Liver Failure
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
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Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Wasowicz, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma drug and drug metabolite concentrations (time frame: 5, 30, 60, 90, 120, 180, 240, 300, 450 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.