Subarachnoid HemorrhageSAHENDONCT00614887
Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Cerebral Aneurysm, run by Kuopio University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebral Aneurysm
- How many people
- 46 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2006to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from acute subarachnoid hemorrhage and patients admitted for elective aneurysm surgery.
Who may be able to join
- SAH-group:
- >age 18,
- Subarachnoid hemorrhage due to an cerebral aneurysm
- Control group:
- Age >18
- Admitted for elective primary cerebral aneurysm surgery
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Intensive Care, Kuopio University Hospital
Kuopio, PL 1777, 70211
About this study
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.
Read the 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.
- Conditions
- Subarachnoid Hemorrhage, Cerebral Aneurysm
- Keywords
- Subarachnoid hemorrhage, Pituitary gland, Adrenal gland
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Patients scheduled for elective cerebral aneurysmal surgery | |
| 1 | Patients with subarachnoid hemorrhage |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMar 2006
- Primary completionNov 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Investigators
- Stepani J Bendel, MD, Principal investigator, Department of Intensive Care, Kuopio University Hospital, FINLANDAri Uusaro, MD, Phd, Study director, Department of Intensive Care, Kuopio University Hospital, FINLANDTimo Koivisto, MD, Phd, Study director, Department of Neurosurgery, Kuopio Universtiy Hospital, FINLAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614887
- Sponsor's protocol ID
- KUH5070184
- Other IDs
- 5070184
- Acronym
- SAHENDO
- Status last verified
- Jan 2008
- First submitted
- 31 Jan 2008
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20426845Bendel 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.
PubMed 18851750
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT00614887
- Acronym / sponsor ID
- SAHENDO / KUH5070184
- Conditions
- Subarachnoid Hemorrhage, Cerebral Aneurysm
- Keywords
- Subarachnoid hemorrhage, Pituitary gland, Adrenal gland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Mar 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –Patients scheduled for elective cerebral aneurysmal surgery |
| 1 | – | –Patients with subarachnoid hemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from acute subarachnoid hemorrhage and patients admitted for elective aneurysm surgery.
Key inclusion criteria (6 listed)
- >age 18,
- Subarachnoid hemorrhage due to an cerebral aneurysm
- Age >18
- Admitted for elective primary cerebral aneurysm surgery
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 20426845Bendel 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.
- Derived from this study: PubMed 18851750Bendel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stepani J Bendel, MD principal investigator
Department of Intensive Care, Kuopio University Hospital, FINLAND
Ari Uusaro, MD, Phd study director
Department of Intensive Care, Kuopio University Hospital, FINLAND
Timo Koivisto, MD, Phd study director
Department of Neurosurgery, Kuopio Universtiy Hospital, FINLAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Cerebral Aneurysm, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00614887, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.