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Thyroxine Replacement in Organ Donors

Primary Purpose

Brain Death

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
L-thryoxine
iv thryoxine
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Death focused on measuring organ donation, thyroid replacement

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Brain death criteria established Consent for organ donation received Exclusion Criteria: 1. immediate (< 4 Hrs) organ retrieval anticipated

Sites / Locations

  • London Health Sciences Centre-UC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

po thyroxine

iv thyroxine

Arm Description

placebo is iv

placebo is po

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pharmacokinetic profiles of oral vs iv T3,T4
number of organs donated
thyroid function derangements at time of brain death

Full Information

First Posted
October 12, 2005
Last Updated
January 4, 2011
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00238030
Brief Title
Thyroxine Replacement in Organ Donors
Official Title
Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death
Keywords
organ donation, thyroid replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
po thyroxine
Arm Type
Active Comparator
Arm Description
placebo is iv
Arm Title
iv thyroxine
Arm Type
Active Comparator
Arm Description
placebo is po
Intervention Type
Drug
Intervention Name(s)
L-thryoxine
Other Intervention Name(s)
L-thyroxine, Eltroxin
Intervention Description
2 mcg/kg iv or 2 mcg/kg po at time of enrollment
Intervention Type
Drug
Intervention Name(s)
iv thryoxine
Other Intervention Name(s)
L-thyroxine, Eltroxin
Intervention Description
thyroxine 2 mcg/kg iv
Primary Outcome Measure Information:
Title
Percentage of time patients require inotropic support prior to organ procurement.
Time Frame
every hour following administration
Secondary Outcome Measure Information:
Title
pharmacokinetic profiles of oral vs iv T3,T4
Time Frame
hourly from time of administration
Title
number of organs donated
Time Frame
total number of organs donated at time of procurement
Title
thyroid function derangements at time of brain death
Time Frame
thyroid function q 4hrs following declaration of brain death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Brain death criteria established Consent for organ donation received Exclusion Criteria: 1. immediate (< 4 Hrs) organ retrieval anticipated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Sharpe, MD FRCPC
Organizational Affiliation
London Health Sciences Centre-UC+
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre-UC
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
2305461
Citation
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. doi: 10.1097/00007890-199002000-00017.
Results Reference
background
PubMed Identifier
23884915
Citation
Sharpe MD, van Rassel B, Haddara W. Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study. Can J Anaesth. 2013 Oct;60(10):998-1002. doi: 10.1007/s12630-013-0004-x. Epub 2013 Jul 25.
Results Reference
derived

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Thyroxine Replacement in Organ Donors

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