Thyroxine Replacement in Organ Donors

January 4, 2011 updated by: Lawson Health Research Institute

Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre-UC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • Eltroxin
  • L-thyroxine
Drug: iv thryoxine
thyroxine 2 mcg/kg iv
Other Names:
  • Eltroxin
  • L-thyroxine
Active Comparator: iv thyroxine
placebo is po
Drug: iv thryoxine
thyroxine 2 mcg/kg iv
Other Names:
  • Eltroxin
  • L-thyroxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time patients require inotropic support prior to organ procurement.
Time Frame: every hour following administration
every hour following administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Estimate)

January 5, 2011

Last Update Submitted That Met QC Criteria

January 4, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-04-298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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