Thyroxine Replacement in Organ Donors

Phase 1

Completed

• Conditions: Brain Death
• Interventions: Drug: L-thryoxine; Drug: iv thryoxine

• Registration Number: NCT00238030
• Lead Sponsor: 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

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 Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Primary Completion: 2009-05
• Study Completion: 2010-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-04
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Read More

Exclusion Criteria

1. immediate (< 4 Hrs) organ retrieval anticipated

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
po thyroxine	L-thryoxine	placebo is iv
po thyroxine	iv thryoxine	placebo is iv
iv thyroxine	iv thryoxine	placebo is po

Primary Outcome Measures

Name	Time	Method
Percentage of time patients require inotropic support prior to organ procurement.	every hour following administration

Secondary Outcome Measures

Name	Time	Method
pharmacokinetic profiles of oral vs iv T3,T4	hourly from time of administration
number of organs donated	total number of organs donated at time of procurement
thyroid function derangements at time of brain death	thyroid function q 4hrs following declaration of brain death

Trial Locations

Locations (1)

London Health Sciences Centre-UC; 🇨🇦 London, Ontario, Canada