Thyroxine Replacement in Organ Donors

Brain Death Clinical Trial

Official title:

Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238030
• Other study ID #: R-04-298
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 12, 2005
• Last updated: January 4, 2011
• Start date: December 2004
• Est. completion date: October 2010

Study information

• Verified date: January 2011
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Brain death criteria established

2. Consent for organ donation received

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Death

Intervention

Drug:
• L-thryoxine
2 mcg/kg iv or 2 mcg/kg po at time of enrollment
• iv thryoxine
thyroxine 2 mcg/kg iv

Locations

Country	Name	City	State
Canada	London Health Sciences Centre-UC	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Novitzky D, Cooper DK, Chaffin JS, Greer AE, DeBault LE, Zuhdi N. Improved cardiac allograft function following triiodothyronine therapy to both donor and recipient. Transplantation. 1990 Feb;49(2):311-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time patients require inotropic support prior to organ procurement.		every hour following administration	No
Secondary	pharmacokinetic profiles of oral vs iv T3,T4		hourly from time of administration	No
Secondary	number of organs donated		total number of organs donated at time of procurement	No
Secondary	thyroid function derangements at time of brain death		thyroid function q 4hrs following declaration of brain death	No