Hypopituitarism After Aneurismal Subarachnoid Hemorrhage

Sponsor
Universitätsmedizin Mannheim (Other)
Overall Status
Completed
CT.gov ID
NCT00962559
Collaborator
(none)
26
1
24
1.1

Study Details

Study Description

Brief Summary

Introduction:

Almost 50% of patients die after aneurismal subarachnoid hemorrhage (aSAH). 30% of the survivors suffer from neurological handicap and need permanent care (Suarez et al.). Even when neurological outcome is good, neuropsychological deficits are frequently observed (Ogden et al., Anderson et al.) The incidence rate of aSAH is almost 8 of 100.000 per year. Due to similar clinical symptoms to patients with hypopituitarism, several studies have analyzed the incidence of hypopituitarism after aSAH. Dysfunction of the anterior pituitary gland was found in up to 47% (Schneider et al.). GH deficiency was demonstrated in almost every fourth patient and an association with poor recovery was postulated. In Germany, the investigators would therefore expect as many as 1200 patients with incident GH deficiency. The KIMS-study is an observational GH-treatment study in adult onset growth hormone deficiency. Within the epidemiological data of KIMS, aSAH is not known as a relevant contributing cause (Brabant et al.). This resembles much of the investigators clinical experience that there is no huge prevalence of hypopituitarism after aSAH.

Objective: Evaluation of the frequency of hypopituitarism and neuropsychological dysfunction of any degree in patients with aSAH in a prospective approach.

Methods:

The investigators conduct a prospective study for the evaluation of endocrine deficiency with aSAH. The investigators study patients 3, 6 and 12 month after aneurismal bleeding. Patients diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in the study. The investigators perform basal testing for the pituitary by measuring: TSH, LH, FSH, IGF-1, GH, prolactin and ACTH. For evaluation of the adrenal function the investigators perform an ACTH-stimulation test (Lindholm et al.). Subjects with evidence for adrenal or GH insufficiency are further analyzed by insulin-induced hypoglycemia testing (GH Research Society). In the neuropsychological examination, the investigators screen for verbal comprehension (Token Test, short form) and visual neglect (line bisection). Verbal and visual short term memory (digit and spatial span), visuospatial construction and figural memory (Rey Osterrieth Complex Figure Test), psychomotor speed, attention and concentration (Trail Making Test Part A and B, d2) as well as mental flexibility (word fluency) are assessed. Patients additionally fill out a questionnaire measuring actual depressive symptoms and anxiety (Hospital Anxiety and Depression Scale).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    26 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Endocrine and Neuropsychological Changes After Aneurismal Subarachnoid Hemorrhage.
    Study Start Date :
    Feb 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2010
    Actual Study Completion Date :
    Feb 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. hypopituitarism of any degree [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • aSAH grade I-IV Hunt und Hess

    • bleeding CCT Fisher grade 3-4

    • therapy within 48h after aSAH

    • preoperative angiography as well as control angiography

    • Glasgow Outcome Scale 4 to 5 after therapy

    Exclusion Criteria:
    • known intra-, peri- or suprasellar neoplasia

    • preexisting hypopituitarism of any degree

    • previous hormonal substitution

    • previous radiation

    • for the neuropsychological examination: difficulties with German language

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsmedizin Mannheim Mannheim BW Germany 68169

    Sponsors and Collaborators

    • Universitätsmedizin Mannheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00962559
    Other Study ID Numbers:
    • aSAH and Hypopituitarism 0815
    First Posted:
    Aug 20, 2009
    Last Update Posted:
    Feb 17, 2010
    Last Verified:
    Feb 1, 2010
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2010