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Thyroxine Replacement in Organ Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238030
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : January 5, 2011
Information provided by:
Lawson Health Research Institute

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 thyroid administration

Condition or disease Intervention/treatment Phase
Brain Death Drug: L-thryoxine Drug: iv thryoxine Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors
Study Start Date : December 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Active Comparator: po thyroxine
placebo is iv
Drug: L-thryoxine
2 mcg/kg iv or 2 mcg/kg po at time of enrollment
Other Names:
  • L-thyroxine
  • Eltroxin

Drug: iv thryoxine
thyroxine 2 mcg/kg iv
Other Names:
  • L-thyroxine
  • Eltroxin

Active Comparator: iv thyroxine
placebo is po
Drug: iv thryoxine
thyroxine 2 mcg/kg iv
Other Names:
  • L-thyroxine
  • Eltroxin

Primary Outcome Measures :
  1. Percentage of time patients require inotropic support prior to organ procurement. [ Time Frame: every hour following administration ]

Secondary Outcome Measures :
  1. pharmacokinetic profiles of oral vs iv T3,T4 [ Time Frame: hourly from time of administration ]
  2. number of organs donated [ Time Frame: total number of organs donated at time of procurement ]
  3. thyroid function derangements at time of brain death [ Time Frame: thyroid function q 4hrs following declaration of brain death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238030

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Canada, Ontario
London Health Sciences Centre-UC
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre-UC+
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Michael D Sharpe, London Health Sciences Centre - University Hospital Identifier: NCT00238030    
Other Study ID Numbers: R-04-298
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: January 2011
Keywords provided by Lawson Health Research Institute:
organ donation
thyroid replacement
Additional relevant MeSH terms:
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Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes