Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01761344
First received: January 2, 2013
Last updated: August 28, 2013
Last verified: August 2013

January 2, 2013
August 28, 2013
January 2013
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01761344 on ClinicalTrials.gov Archive Site
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Intraoperative Analysis of Cortisol During Adrenal Vein Sampling
Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.

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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Primary Hyperaldosteronism
Other: Intraoperative cortisol measurement.
Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure
Experimental: Intraoperative measurement of cortisol
Intervention: During a routine procedure intraoperative cortisol is measured. Upon unsuccessful sampling, the sampling will be repeated.
Intervention: Other: Intraoperative cortisol measurement.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01761344
2012/1856
No
Haukeland University Hospital
Haukeland University Hospital
Not Provided
Study Chair: Gunnar Mellgren, MD.PhD Hormonlaboratoriet, Haukeland Universitetssykehus
Haukeland University Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP