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Thyroxine Replacement in Organ Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00238030
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : January 5, 2011
Sponsor:
Information provided by:
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE October 12, 2005
First Posted Date  ICMJE October 13, 2005
Last Update Posted Date January 5, 2011
Study Start Date  ICMJE December 2004
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
Percentage of time patients require inotropic support prior to organ procurement. [ Time Frame: every hour following administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2005)
Percentage of time patients require inotropic support prior to organ procurement.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
  • pharmacokinetic profiles of oral vs iv T3,T4 [ Time Frame: hourly from time of administration ]
  • number of organs donated [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2005)
  • 1. pharmacokinetic profiles of oral vs iv T3,T4
  • 2. number of organs donate
  • 3. thryoid function derangements at time of brain death
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thyroxine Replacement in Organ Donors
Official Title  ICMJE Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Death
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: po thyroxine
    placebo is iv
    Interventions:
    • Drug: L-thryoxine
    • Drug: iv thryoxine
  • Active Comparator: iv thyroxine
    placebo is po
    Intervention: Drug: iv thryoxine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2011)
34
Original Enrollment  ICMJE
 (submitted: October 12, 2005)
30
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

1. immediate (< 4 Hrs) organ retrieval anticipated

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00238030
Other Study ID Numbers  ICMJE R-04-298
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Michael D Sharpe, London Health Sciences Centre - University Hospital
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre-UC+
PRS Account Lawson Health Research Institute
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP