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Thyroxine Replacement in Organ Donors
This study is currently recruiting participants.
Study NCT00238030   Information provided by Lawson Health Research Institute
First Received: October 12, 2005   Last Updated: December 14, 2005   History of Changes

October 12, 2005
December 14, 2005
December 2004
 
Percentage of time patients require inotropic support prior to organ procurement.
Same as current
Complete list of historical versions of study NCT00238030 on ClinicalTrials.gov Archive Site
  • 1. pharmacokinetic profiles of oral vs iv T3,T4
  • 2. number of organs donate
  • 3. thryoid function derangements at time of brain death
Same as current
 
Thyroxine Replacement in Organ Donors
Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors

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

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Brain Death
Drug: L-thryoxine
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
 
 

Inclusion Criteria:

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

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

Both
16 Years and older
Yes
Contact: Michael D Sharpe, MD FRCPC 519-663-3030 michael.sharpe@lhsc.on.ca
Canada
 
NCT00238030
 
R-04-298
Lawson Health Research Institute
 
Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre-UC+
Lawson Health Research Institute
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP