Hypopituitarism After Aneurismal Subarachnoid Hemorrhage

Hypopituitarism Clinical Trial

Official title:

Endocrine and Neuropsychological Changes After Aneurismal Subarachnoid Hemorrhage.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962559
• Other study ID #: aSAH and Hypopituitarism 0815
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: February 16, 2010
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurismal Subarachnoid Hemorrhage
• Hemorrhage
• Hypopituitarism
• Neuropsychological Deficits
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
Germany	Universitätsmedizin Mannheim	Mannheim	BW

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Anderson SW, Todd MM, Hindman BJ, Clarke WR, Torner JC, Tranel D, Yoo B, Weeks J, Manzel KW, Samra S; IHAST Investigators. Effects of intraoperative hypothermia on neuropsychological outcomes after intracranial aneurysm surgery. Ann Neurol. 2006 Nov;60(5):518-27. — View Citation

Brabant G, Krogh Rasmussen A, Biller BM, Buchfelder M, Feldt-Rasmussen U, Forssmann K, Jonsson B, Koltowska-Haggstrom M, Maiter D, Saller B, Toogood A. Clinical implications of residual growth hormone (GH) response to provocative testing in adults with severe GH deficiency. J Clin Endocrinol Metab. 2007 Jul;92(7):2604-9. Epub 2007 May 8. — View Citation

Growth Hormone Research Society. Consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research Society. GH Research Society. J Clin Endocrinol Metab. 2000 Nov;85(11):3990-3. — View Citation

Lindholm J, Kehlet H. Re-evaluation of the clinical value of the 30 min ACTH test in assessing the hypothalamic-pituitary-adrenocortical function. Clin Endocrinol (Oxf). 1987 Jan;26(1):53-9. — View Citation

Ogden JA, Mee EW, Henning M. A prospective study of impairment of cognition and memory and recovery after subarachnoid hemorrhage. Neurosurgery. 1993 Oct;33(4):572-86; discussion 586-7. — View Citation

Schneider HJ, Kreitschmann-Andermahr I, Ghigo E, Stalla GK, Agha A. Hypothalamopituitary dysfunction following traumatic brain injury and aneurysmal subarachnoid hemorrhage: a systematic review. JAMA. 2007 Sep 26;298(12):1429-38. Review. — View Citation

Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006 Jan 26;354(4):387-96. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypopituitarism of any degree		one year	Yes