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Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

Primary Purpose

Primary Hyperaldosteronism

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intraoperative cortisol measurement.
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Hyperaldosteronism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative measurement of cortisol

Arm Description

Intervention: During a routine procedure intraoperative cortisol is measured. Upon unsuccessful sampling, the sampling will be repeated.

Outcomes

Primary Outcome Measures

Representative blood sample from adrenal veins bilaterally.
Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2013
Last Updated
August 28, 2013
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01761344
Brief Title
Intraoperative Analysis of Cortisol During Adrenal Vein Sampling
Official Title
Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperaldosteronism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative measurement of cortisol
Arm Type
Experimental
Arm Description
Intervention: During a routine procedure intraoperative cortisol is measured. Upon unsuccessful sampling, the sampling will be repeated.
Intervention Type
Other
Intervention Name(s)
Intraoperative cortisol measurement.
Intervention Description
Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure
Primary Outcome Measure Information:
Title
Representative blood sample from adrenal veins bilaterally.
Description
Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.
Time Frame
Intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Mellgren, MD.PhD
Organizational Affiliation
Hormonlaboratoriet, Haukeland Universitetssykehus
Official's Role
Study Chair
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5020
Country
Norway

12. IPD Sharing Statement

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Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

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