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Thyroxine Replacement in Organ Donors

This study is currently recruiting participants.
Study NCT00238030.   Last updated on December 14, 2005.   Information provided by Lawson Health Research Institute

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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

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.

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
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:

  1. Brain death criteria established
  2. Consent for organ donation received

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Michael D Sharpe, MD FRCPC     519-663-3030     michael.sharpe@lhsc.on.ca    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00238030
Organization ID R-04-298
Secondary IDs ††
Study Sponsor  Lawson Health Research Institute
Collaborators ††
Investigators 
Principal Investigator:     Michael D Sharpe, MD FRCPC     London Health Sciences Centre-UC+    
Information Provided By Lawson Health Research Institute
Verification Date October 2005
First Received Date  October 12, 2005
Last Updated Date December 14, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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