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
  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: 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.

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01761344     History of Changes
Other Study ID Numbers: 2012/1856
Study First Received: January 2, 2013
Last Updated: August 28, 2013
Health Authority: Norway: Ethics Committee

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

ClinicalTrials.gov processed this record on April 16, 2014