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Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage (SAHENDO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614887
First Posted: February 13, 2008
Last Update Posted: February 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Eastern Finland
Information provided by:
Kuopio University Hospital
  Purpose

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.


Condition
Subarachnoid Hemorrhage Cerebral Aneurysm

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Biospecimen Retention:   Samples Without DNA
serum and plasma samples

Enrollment: 46
Study Start Date: March 2006
Study Completion Date: January 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
2
Patients scheduled for elective cerebral aneurysmal surgery
1
Patients with subarachnoid hemorrhage

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from acute subarachnoid hemorrhage and patients admitted for elective aneurysm surgery.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614887


Locations
Finland
Department of Intensive Care, Kuopio University Hospital
Kuopio, Pl 1777, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
Investigators
Principal Investigator: Stepani J Bendel, MD Department of Intensive Care, Kuopio University Hospital, FINLAND
Study Director: Ari Uusaro, MD, Phd Department of Intensive Care, Kuopio University Hospital, FINLAND
Study Director: Timo Koivisto, MD, Phd Department of Neurosurgery, Kuopio Universtiy Hospital, FINLAND
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bendel Stepani, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00614887     History of Changes
Other Study ID Numbers: KUH5070184
5070184
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: February 13, 2008
Last Verified: January 2008

Keywords provided by Kuopio University Hospital:
Subarachnoid hemorrhage
Pituitary gland
Adrenal gland

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Brain Diseases
Hemorrhage
Subarachnoid Hemorrhage
Pituitary Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Endocrine System Diseases
Intracranial Arterial Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents