Thyroxine Replacement in Organ Donors

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00238030
First received: October 12, 2005
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Brain Death
Drug: L-thryoxine
Drug: iv thryoxine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Percentage of time patients require inotropic support prior to organ procurement. [ Time Frame: every hour following administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pharmacokinetic profiles of oral vs iv T3,T4 [ Time Frame: hourly from time of administration ] [ Designated as safety issue: No ]
  • number of organs donated [ Time Frame: total number of organs donated at time of procurement ] [ Designated as safety issue: No ]
  • thyroid function derangements at time of brain death [ Time Frame: thyroid function q 4hrs following declaration of brain death ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: December 2004
Study Completion Date: October 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • L-thyroxine
  • Eltroxin
Drug: iv thryoxine
thyroxine 2 mcg/kg iv
Other Names:
  • L-thyroxine
  • Eltroxin
Active Comparator: iv thyroxine
placebo is po
Drug: iv thryoxine
thyroxine 2 mcg/kg iv
Other Names:
  • L-thyroxine
  • Eltroxin

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238030

Locations
Canada, Ontario
London Health Sciences Centre-UC
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre-UC+
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Michael D Sharpe, London Health Sciences Centre - University Hospital
ClinicalTrials.gov Identifier: NCT00238030     History of Changes
Other Study ID Numbers: R-04-298
Study First Received: October 12, 2005
Last Updated: January 4, 2011
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
organ donation
thyroid replacement

Additional relevant MeSH terms:
Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014