NCT00238030

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 5, 2011

Status Verified

January 1, 2011

Enrollment Period

4.4 years

First QC Date

October 12, 2005

Last Update Submit

January 4, 2011

Conditions

Brain Death

Keywords

organ donationthyroid replacement

Outcome Measures

Primary Outcomes (1)

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

    every hour following administration

Secondary Outcomes (3)

  • pharmacokinetic profiles of oral vs iv T3,T4

    hourly from time of administration

  • number of organs donated

    total number of organs donated at time of procurement

  • thyroid function derangements at time of brain death

    thyroid function q 4hrs following declaration of brain death

Study Arms (2)

po thyroxine

ACTIVE COMPARATOR

placebo is iv

Drug: L-thryoxineDrug: iv thryoxine

iv thyroxine

ACTIVE COMPARATOR

placebo is po

Drug: iv thryoxine

Interventions

L-thryoxineDRUG

2 mcg/kg iv or 2 mcg/kg po at time of enrollment

Also known as: L-thyroxine, Eltroxin
po thyroxine
iv thryoxineDRUG

thyroxine 2 mcg/kg iv

Also known as: L-thyroxine, Eltroxin
iv thyroxinepo thyroxine

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Brain death criteria established
  • Consent for organ donation received

You may not qualify if:

  • \. immediate (\< 4 Hrs) organ retrieval anticipated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre-UC

London, Ontario, N6A5A5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 2305461BACKGROUND

  • 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.

    PMID: 23884915DERIVED

MeSH Terms

Conditions

Brain Death

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Michael D Sharpe, MD FRCPC

    London Health Sciences Centre-UC+

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2009

Study Completion

October 1, 2010

Last Updated

January 5, 2011

Record last verified: 2011-01

Locations

CA(1)