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| Descriptive Information Fields | |||||
| Brief Title † | Thyroxine Replacement in Organ Donors | ||||
| Official Title † | Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors | ||||
| Brief Summary | To compare oral versus intravenous administration of thyroid hormone: 1) for reversibility of hemodynamic instability in organ donors, and, 2) the pharmacokinetics of oral vs iv thryoid administration |
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| Detailed Description | Disruption of the hypothalamic-pituitary axis following brain death may lead to hemodynamic instability, peripheral vasodilation, and diabetes insipidus in organ donors, requiring the use of high doses of inotropes. Inotropes may cause ischemic injury to organs and intramyocardial ATP stores, resulting in organs unsuitable for transplantation, as well as, a reduction in post-transplant organ function. Therefore, some clinicians advocate the use of triple hormonal therapy in potential organ donors. 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Percentage of time patients require inotropic support prior to organ procurement. | ||||
| Secondary Outcome Measure † | 1. pharmacokinetic profiles of oral vs iv T3,T4 2. number of organs donate 3. thryoid function derangements at time of brain death |
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| Condition † | Brain Death | ||||
| Intervention † | Drug: L-thryoxine | ||||
| MEDLINE PMIDs | 2305461 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 30 | ||||
| Start Date † | December 2004 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: 1. immediate (< 4 Hrs) organ retrieval anticipated |
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00238030 | ||||
| Organization ID | R-04-298 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Lawson Health Research Institute | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Lawson Health Research Institute | ||||
| Verification Date | October 2005 | ||||
| First Received Date † | October 12, 2005 | ||||
| Last Updated Date | December 14, 2005 | ||||
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