Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage

NCT ID: NCT00614887

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Subarachnoid Hemorrhage Cerebral Aneurysm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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2

Patients scheduled for elective cerebral aneurysmal surgery

No interventions assigned to this group

1

Patients with subarachnoid hemorrhage

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kuopio University Hospital

Principal Investigators

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Stepani J Bendel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care, Kuopio University Hospital, FINLAND

Ari Uusaro, MD, Phd

Role: STUDY_DIRECTOR

Department of Intensive Care, Kuopio University Hospital, FINLAND

Timo Koivisto, MD, Phd

Role: STUDY_DIRECTOR

Department of Neurosurgery, Kuopio Universtiy Hospital, FINLAND

Locations

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Department of Intensive Care, Kuopio University Hospital

Kuopio, PL 1777, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 20426845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18851750 (View on PubMed)

Other Identifiers

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5070184

Identifier Type: -

Identifier Source: secondary_id

KUH5070184

Identifier Type: -

Identifier Source: org_study_id

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