Intraoperative Analysis of Cortisol During Adrenal Vein Sampling
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.|
- Representative blood sample from adrenal veins bilaterally. [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.
|Study Start Date:||January 2013|
|Study Completion Date:||August 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Intraoperative measurement of cortisol
Intervention: During a routine procedure intraoperative cortisol is measured. Upon unsuccessful sampling, the sampling will be repeated.
Other: Intraoperative cortisol measurement.
Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761344
|Haukeland University Hospital|
|Bergen, Hordaland, Norway, 5020|
|Study Chair:||Gunnar Mellgren, MD.PhD||Hormonlaboratoriet, Haukeland Universitetssykehus|