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临床试验/NCT04528797
NCT04528797已完成不适用

Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement

Medical University of South Carolina0 个研究点目标入组 199 人开始时间: 2010年9月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
199
主要终点
Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.

研究概览

简要总结

Brain death inevitably leads to hemodynamic instability and prolonged hypotension that compromises viability of potentially transplantable organs. In addition to depletion of peripheral norepinephrine stores, concomitant depletion of thyroid hormone and cortisol levels are believed to contribute to this instability. Catecholamine vasopressors are widely used to support hemodynamics in potential organ donors, however their use has also been shown to compromise allograft function.

Trials studying the effects of thyroid hormone and corticosteroid treatment on brain dead organ donors have had mixed results with respect to improving donor hemodynamics. Further, few studies have attempted to discriminate the relative contribution of thyroid hormone vs. corticosteroids.

The specific aims of this study include:

  1. To quantify hemodynamic changes during the management of cadaveric organ donors routinely receiving thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those who do not receive any hormonal therapy (controls)
  2. To document number and types of organs procured in donors treated with thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those not treated with hormonal therapy (controls)
  3. To quantify graft and patient outcomes in recipients of organs exposed to thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to recipients of organs not exposed to hormonal therapy (controls).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Cadaveric organ donors ≥ age 18 having valid consent (by advance directive or by familial consent) to donate organs.
  • Recipients of these cadaveric organs

排除标准

  • Cadavers failing to meet inclusion criteria

研究组 & 干预措施

Methylprednisolone

Experimental

Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later.

干预措施: Methylprednisolone (Drug)

Levothyroxine

Experimental

Levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement.

干预措施: Levothyroxine (Drug)

Combination

Experimental

Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later plus levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement.

干预措施: Levothyroxine (Drug)

Combination

Experimental

Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later plus levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement.

干预措施: Methylprednisolone (Drug)

结局指标

主要结局

Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.

时间窗: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours

The VIS score includes all commonly used vasopressor and inotrope agents, weighted by potency and summed

次要结局

  • Recipient Morbidity(90 days post transplant)
  • Proportion of organs procured vs. consented, stratified by treatment group(assessed at time of procurement, up to 50 hours following consent for donation)
  • Recipient Mortality(90 days post traansplant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Van Bakel

Professor of Medicine

Medical University of South Carolina

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