Partial Corticotrope Insufficiency Clinical Trial
Official title:
Phase IV Study to Evaluate the Neuropsychological Effects of Hydrocortisone Substitution in Patients With Partial Adrenal Insufficiency After Traumatic Brain Injury or Subarachnoidal Haemorrhage
The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid hemorrhage on cognitive function.
This is a controlled, randomized, double-blind, placebo-controlled, crossover,
interventional study. The benefit of replacement in partial corticotropic failure on brain
function (cognition), especially in cases with borderline low cortisol levels after
stimulation is unknown.
Moreover, since glucocorticoids might affect hGH secretion, the effect of hydrocortisone on
hGH secretion reflected by IGF-1 levels will be assessed. If IGF-1 is below 2 SD at the end
of the study, hGH secretion will additionally be determined by a GHRH-arginine-test.
An improved cognition in TBI and SAH patients with partial corticotropic insufficiency would
give a new treatment option in this population which may lead to better quality of life and
an enhanced rehabilitation process.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment