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OpenTrials
Completed

NCT Number: NCT00238030

Thyroxine Replacement 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 thyroid administration

Completed

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

London Health Sciences Centre-UC

London, Ontario, N6A5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Brain death criteria established
  • Consent for organ donation received

Exclusion criteria

  • immediate (< 4 Hrs) organ retrieval anticipated

Treatment and study plan

L-thryoxine

Drug

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

Other names: L-thyroxine, Eltroxin

iv thryoxine

Drug

thyroxine 2 mcg/kg iv

Other names: L-thyroxine, Eltroxin

Primary outcomes

  1. Percentage of time patients require inotropic support prior to organ procurement.

    Time frame: every hour following administration

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Oct 13, 2005
Registry last updated
Jan 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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