Clinical trial NCT00614887: Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage
Official title: Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Cerebral Aneurysm
Keywords: Subarachnoid hemorrhage
Pituitary gland
Adrenal gland
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2008-02-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from acute subarachnoid hemorrhage and patients admitted for elective aneurysm surgery.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Department of Intensive Care, Kuopio University Hospital
state: Pl 1777
Study officials:
affiliation: Department of Intensive Care, Kuopio University Hospital, FINLAND
name: Stepani J Bendel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Intensive Care, Kuopio University Hospital, FINLAND
name: Ari Uusaro, MD, Phd
role: STUDY_DIRECTOR
affiliation: Department of Neurosurgery, Kuopio Universtiy Hospital, FINLAND
name: Timo Koivisto, MD, Phd
role: STUDY_DIRECTOR
References:
citation: Bendel S, Koivisto T, Ryynanen OP, Ruokonen E, Romppanen J, Kiviniemi V, Uusaro A. Insulin like growth factor-I in acute subarachnoid hemorrhage: a prospective cohort study. Crit Care. 2010;14(2):R75. doi: 10.1186/cc8988. Epub 2010 Apr 28.
citation: Bendel S, Koivisto T, Ruokonen E, Rinne J, Romppanen J, Vauhkonen I, Kiviniemi V, Uusaro A. Pituitary-adrenal function in patients with acute subarachnoid haemorrhage: a prospective cohort study. Crit Care. 2008;12(5):R126. doi: 10.1186/cc7084. Epub 2008 Oct 13.