Intraoperative Analysis of Cortisol During Adrenal Vein Sampling
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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. |
- 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.
| Estimated Enrollment: | 28 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | August 2013 |
| Estimated 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 |
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| Norway | |
| Haukeland University Hospital | |
| Bergen, Hordaland, Norway, 5020 | |
| 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: | January 3, 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 June 17, 2013