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

October 25, 2023 updated by: Kuopio University Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pl 1777
      • Kuopio, Pl 1777, Finland, 70211
        • Department of Intensive Care, Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
2
Patients scheduled for elective cerebral aneurysmal surgery
1
Patients with subarachnoid hemorrhage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimated)

February 13, 2008

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5070184
  • 5070184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subarachnoid Hemorrhage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe