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Thyroxine Replacement in Organ Donors

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00238030
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
70
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Dec 1, 2004
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of time patients require inotropic support prior to organ procurement. [every hour following administration]

    Secondary Outcome Measures

    1. pharmacokinetic profiles of oral vs iv T3,T4 [hourly from time of administration]

    2. number of organs donated [total number of organs donated at time of procurement]

    3. thyroid function derangements at time of brain death [thyroid function q 4hrs following declaration of brain death]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 London Health Sciences Centre-UC London Ontario Canada N6A5A5

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Michael D Sharpe, MD FRCPC, London Health Sciences Centre-UC+

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00238030
    Other Study ID Numbers:
    • R-04-298
    First Posted:
    Oct 13, 2005
    Last Update Posted:
    Jan 5, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    organ donation
    thyroid replacement
    Additional relevant MeSH terms:
    Brain Death

    Study Results

    No Results Posted as of Jan 5, 2011