跳至主要内容
临床试验/NCT01761344
NCT01761344已完成不适用

Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Representative blood sample from adrenal veins bilaterally.

研究概览

简要总结

Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. The overproduction of aldosteron might in some cases be due to unilateral hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these cases the adrenal can be removed and the patient cured of hypertension. The clinical evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective sampling of blood from the adrenal veins to determine lateralization of overproduction. This is executed as an interventional radiological procedure.

The adrenal vein sampling is challenging, and success is determined by measuring another adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample. By routine laboratory assays the procedure is evaluated after the patient has been discharged from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the radiologist to draw new samples during the same procedure if the first set of samples is unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Primary hyperaldosteronism
  • Motivated for surgery if applicable
  • Able to give informed consent

排除标准

  • Not able to give informed consent
  • Severe kidney failure

结局指标

主要结局

Representative blood sample from adrenal veins bilaterally.

时间窗: Intraoperatively

Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.

次要结局

未报告次要终点

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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