Intraoperative Analysis of Cortisol During Adrenal Vein Sampling

NCT01761344 | Completed

• 1 other identifier: 2012/1856
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hyperaldosteronism

Outcome Measures

Primary Outcomes (1)

• Representative blood sample from adrenal veins bilaterally.

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

  Intraoperatively

Study Arms (1)

Intraoperative measurement of cortisol

EXPERIMENTAL

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

Other: Intraoperative cortisol measurement.

Interventions

Intraoperative cortisol measurement. OTHER

Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure

Intraoperative measurement of cortisol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary hyperaldosteronism
• Motivated for surgery if applicable
• Able to give informed consent

You may not qualify if:

• Not able to give informed consent
• Severe kidney failure

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Hordaland, 5020, Norway

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Gunnar Mellgren, MD.PhD

  Hormonlaboratoriet, Haukeland Universitetssykehus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 4, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

NO (1)