NCT00614887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
Last Updated

October 26, 2023

Status Verified

January 1, 2008

Enrollment Period

8 months

First QC Date

January 31, 2008

Last Update Submit

October 25, 2023

Conditions

Keywords

Subarachnoid hemorrhagePituitary glandAdrenal gland

Study Arms (2)

2

Patients scheduled for elective cerebral aneurysmal surgery

1

Patients with subarachnoid hemorrhage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from acute subarachnoid hemorrhage and patients admitted for elective aneurysm surgery.

You may qualify if:

  • SAH-group:
  • \>age 18,
  • Subarachnoid hemorrhage due to an cerebral aneurysm
  • Control group:
  • Age \>18
  • Admitted for elective primary cerebral aneurysm surgery

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care, Kuopio University Hospital

Kuopio, PL 1777, 70211, Finland

Location

Related Publications (2)

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma samples

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial AneurysmPituitary Diseases

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial Arterial DiseasesAneurysmHypothalamic DiseasesEndocrine System Diseases

Study Officials

  • Stepani J Bendel, MD

    Department of Intensive Care, Kuopio University Hospital, FINLAND

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

March 1, 2006

Primary Completion

November 1, 2006

Study Completion

January 1, 2008

Last Updated

October 26, 2023

Record last verified: 2008-01

Locations