Hypopituitarism After Aneurismal Subarachnoid Hemorrhage
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Purpose
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 |
|---|
|
Aneurismal Subarachnoid Hemorrhage Hypopituitarism Neuropsychological Deficits |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Endocrine and Neuropsychological Changes After Aneurismal Subarachnoid Hemorrhage. |
- hypopituitarism of any degree [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 26 |
| Study Start Date: | February 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in the study.
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
More Information
Publications:
| Responsible Party: | Marcel Seiz, Neurosurgical Department, Universitätsmedizin Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany |
| ClinicalTrials.gov Identifier: | NCT00962559 History of Changes |
| Other Study ID Numbers: | aSAH and Hypopituitarism 0815 |
| Study First Received: | August 19, 2009 |
| Last Updated: | February 16, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Hemorrhage Hypopituitarism Subarachnoid Hemorrhage Pathologic Processes Pituitary Diseases Hypothalamic Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Intracranial Hemorrhages Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013