Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2004-12-31
2010-10-31
Brief Summary
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Detailed Description
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Since intravenous T3(the intracellular active form of thyroxine) is unavailable, oral or intravenous T4 must be used, requiring the conversion of T4 to T3at the cellular level. This conversion is impeded by glucocorticoids which also are administered to organ donors for their immunomodulating effects. Since oral T3 is readily available, our first question is whether oral versus intravenous administration of T4 is comparable. If so, our next study is to determine the efficacy of oral T3 versus oral T4. Our hypothesis is oral T3 is superior to oral T4.
Our study therefore will determine whether or not the oral route is suitable for administration of thyroid replacement therapy. The study will compare the pharmacokinetics of oral versus intravenous T4 administration in organ donors, as well as, determine its ability to wean intropes in this patient population.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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po thyroxine
placebo is iv
L-thryoxine
2 mcg/kg iv or 2 mcg/kg po at time of enrollment
iv thryoxine
thyroxine 2 mcg/kg iv
iv thyroxine
placebo is po
iv thryoxine
thyroxine 2 mcg/kg iv
Interventions
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L-thryoxine
2 mcg/kg iv or 2 mcg/kg po at time of enrollment
iv thryoxine
thyroxine 2 mcg/kg iv
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Consent for organ donation received
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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London Health Sciences Centre - University Hospital
Principal Investigators
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Michael D Sharpe, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre-UC+
Locations
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London Health Sciences Centre-UC
London, Ontario, Canada
Countries
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References
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Novitzky D, Cooper DK, Chaffin JS, Greer AE, DeBault LE, Zuhdi N. Improved cardiac allograft function following triiodothyronine therapy to both donor and recipient. Transplantation. 1990 Feb;49(2):311-6. doi: 10.1097/00007890-199002000-00017.
Sharpe MD, van Rassel B, Haddara W. Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study. Can J Anaesth. 2013 Oct;60(10):998-1002. doi: 10.1007/s12630-013-0004-x. Epub 2013 Jul 25.
Other Identifiers
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R-04-298
Identifier Type: -
Identifier Source: org_study_id
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