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Thyroxine Replacement in Organ Donors

Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00238030
Enrollment
34
Registered
2005-10-13
Start date
2004-12-31
Completion date
2010-10-31
Last updated
2011-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death

Keywords

organ donation, thyroid replacement

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

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.

Interventions

DRUGL-thryoxine

2 mcg/kg iv or 2 mcg/kg po at time of enrollment

DRUGiv thryoxine

thyroxine 2 mcg/kg iv

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Percentage of time patients require inotropic support prior to organ procurement.every hour following administration

Secondary

MeasureTime frame
pharmacokinetic profiles of oral vs iv T3,T4hourly from time of administration
number of organs donatedtotal number of organs donated at time of procurement
thyroid function derangements at time of brain deaththyroid function q 4hrs following declaration of brain death

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026