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临床试验/NCT00238030
NCT00238030已完成1 期

Efficacy and Pharmacokinetics of Oral Thyroid Replacement Therapy in Organ Donors

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Percentage of time patients require inotropic support prior to organ procurement.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Brain death criteria established
  • Consent for organ donation received

排除标准

  • immediate (< 4 Hrs) organ retrieval anticipated

研究组 & 干预措施

po thyroxine

Active Comparator

placebo is iv

干预措施: L-thryoxine (Drug)

po thyroxine

Active Comparator

placebo is iv

干预措施: iv thryoxine (Drug)

iv thyroxine

Active Comparator

placebo is po

干预措施: iv thryoxine (Drug)

结局指标

主要结局

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

时间窗: every hour following administration

次要结局

  • 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)

研究者

申办方类型
Other

研究点 (1)

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