Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

Primary Hyperaldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761344
• Other study ID #: 2012/1856
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: August 28, 2013
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary hyperaldosteronism

• Motivated for surgery if applicable

• Able to give informed consent

Exclusion Criteria:

• Not able to give informed consent

• Severe kidney failure

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Hyperaldosteronism

Intervention

Other:
• Intraoperative cortisol measurement.
Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Representative blood sample from adrenal veins bilaterally.	Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.	Intraoperatively	No