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Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761344
First Posted: January 4, 2013
Last Update Posted: August 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Haukeland University Hospital
  Purpose

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.


Condition Intervention
Primary Hyperaldosteronism Other: Intraoperative cortisol measurement.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Representative blood sample from adrenal veins bilaterally. [ Time Frame: Intraoperatively ]
    Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.


Enrollment: 21
Study Start Date: January 2013
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761344


Locations
Norway
Haukeland University Hospital
Bergen, Hordaland, Norway, 5020
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Chair: Gunnar Mellgren, MD.PhD Hormonlaboratoriet, Haukeland Universitetssykehus
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01761344     History of Changes
Other Study ID Numbers: 2012/1856
First Submitted: January 2, 2013
First Posted: January 4, 2013
Last Update Posted: August 29, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents