Hypopituitarism Clinical Trial
Official title:
Endocrine and Neuropsychological Changes After Aneurismal Subarachnoid Hemorrhage.
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).
n/a
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02871986 -
Pubertal Induction in Individuals With Hypogonadism
|
N/A | |
Completed |
NCT00851942 -
Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test
|
Phase 4 | |
Completed |
NCT00507104 -
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
|
||
Completed |
NCT01088399 -
A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults
|
N/A | |
Completed |
NCT00027430 -
Androgen Replacement Therapy in Women With Hypopituitarism
|
N/A | |
Recruiting |
NCT04897802 -
Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)
|
Phase 4 | |
Not yet recruiting |
NCT06014398 -
Improving Survivorship and Health-related Quality of Life in Patients With Primary Brain Tumours
|
N/A | |
Recruiting |
NCT04121780 -
Growth Hormone Replacement Therapy for Retried Professional Football Players
|
Phase 2 | |
Not yet recruiting |
NCT01666964 -
Hormone Deficiency After Brain Injury During Combat
|
N/A | |
Completed |
NCT01028742 -
Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity
|
N/A | |
Completed |
NCT00139945 -
Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
|
N/A | |
Completed |
NCT05206149 -
Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes
|
Phase 4 | |
Completed |
NCT05188131 -
Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium
|
Phase 4 | |
Completed |
NCT00133354 -
Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT03708523 -
Next Day Growth Hormone Predicting Pituitary Function After Adenomectomy
|
||
Completed |
NCT01007071 -
Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency
|
Phase 3 | |
Completed |
NCT00080483 -
Testosterone and Growth Hormone for Bone Loss in Men
|
Phase 2 | |
Completed |
NCT01009905 -
An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)
|
N/A | |
Completed |
NCT01209416 -
The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin
|
N/A | |
Completed |
NCT04902235 -
Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)
|
Phase 4 |