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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614887
Other study ID # KUH5070184
Secondary ID 5070184
Status Completed
Phase
First received
Last updated
Start date March 2006
Est. completion date January 2008

Study information

Verified date January 2008
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Subarachnoid haemorrhage (SAH) may cause damage to the hypotalamo-pituitary-adrenal axis (HPA) thus disturbing the hormonal response of these structures. The aim of our study is to characterize the function of HPA-axis acutely and over time up to three months in patients with SAH.


Description:

The hypotalamo-pituitary-adrenal (HPA)-axis may be affected in SAH by temporary or permanent damage to the hypothalamus and/or pituitary gland. Also surgery or endovascular treatment of a ruptured intracranial aneurysm may affect the hormonal response of the HPA-axis. Some data suggest a high incidence of delayed endocrine abnormalities in patients with SAH but only little data exists on the acute endocrine abnormalities in this disease. We will study the pituitary-adrenal hormone levels in patients with acute aneurysmal SAH and patients admitted for elective cranial aneurysm surgery will serve as a control population. We will use serum free cortisol calculation and total cortisol measurements as well as adrenocorticotrophic hormone (ACTH) stimulation test in assessing the responsiveness of the adrenal gland to exogenous ACTH. The hormone levels will be measured repeatedly during the first seven days after SAH and once at three months.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date January 2008
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: SAH-group: - >age 18, - Subarachnoid hemorrhage due to an cerebral aneurysm Control group: - Age >18 - Admitted for elective primary cerebral aneurysm surgery Exclusion Criteria: SAH group: - Any corticoid treatment (also inhaled) - Usage of etomidate before study entry or during the study period - Exact bleeding day unknown - Previous history of SAH or more than three days of current bleeding - Previous aneurysm surgery or embolization - Traumatic SAH - Known pituitary insufficiency and moribund state of the patient - Refusement of the patient control group: - Any corticoid treatment (also inhaled) - Usage of etomidate before study entry or during the study period - Previous history of SAH or cerebral aneurym surgery or embolization - Admitted for elective aneurysm embolization - Known pituitary insufficiency - Refusement of the patienT

Study Design


Locations

Country Name City State
Finland Department of Intensive Care, Kuopio University Hospital Kuopio Pl 1777

Sponsors (2)

Lead Sponsor Collaborator
Kuopio University Hospital University of Eastern Finland

Country where clinical trial is conducted

Finland, 

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