Intraoperative Analysis of Cortisol During Adrenal Vein Sampling
Information source: Haukeland University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Hyperaldosteronism
Intervention: Intraoperative cortisol measurement. (Other)
Phase: N/A
Status: Completed
Sponsored by: Haukeland University Hospital Official(s) and/or principal investigator(s):
Gunnar Mellgren, MD.PhD, Study Chair, Affiliation: Hormonlaboratoriet, Haukeland Universitetssykehus
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.
Clinical Details
Official title: Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Representative blood sample from adrenal veins bilaterally.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Haukeland University Hospital, Bergen, Hordaland 5020, Norway
Additional Information
Starting date: January 2013
Last updated: August 28, 2013
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