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Thyroxine Replacement in Organ Donors
This study is currently recruiting participants.
Verified by Lawson Health Research Institute, October 2005
Sponsored by: Lawson Health Research Institute
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00238030
  Purpose

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


Condition Intervention Phase
Brain Death
Drug: L-thryoxine
Phase I
Phase II

Drug Information available for: Levothyroxine Sodium Thyroxine Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Percentage of time patients require inotropic support prior to organ procurement.

Secondary Outcome Measures:
  • 1. pharmacokinetic profiles of oral vs iv T3,T4
  • 2. number of organs donate
  • 3. thryoid function derangements at time of brain death

Estimated Enrollment: 30
Study Start Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238030

Contacts
Contact: Michael D Sharpe, MD FRCPC 519-663-3030 michael.sharpe@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre-UC Recruiting
London, Ontario, Canada, N6A5A5
Contact: Michael D Sharpe     519-663-3030     michael.sharpe@lhsc.on.ca    
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre-UC+
  More Information

Publications:
Study ID Numbers: R-04-298
Study First Received: October 12, 2005
Last Updated: December 14, 2005
ClinicalTrials.gov Identifier: NCT00238030  
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
organ donation
thyroid replacement

Study placed in the following topic categories:
Coma
Unconsciousness
Death
Brain Death
Consciousness Disorders
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Neurobehavioral Manifestations

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009