hormonal deficiency after traumatic-brain- injury (TBI) or subarachnoidal haemorrhage (SAH) MedDRA version: 12.1 Level: LLT Classification code 10011198 Term: Cortisol decreased
Conditions
Interventions
Trade Name: Hydrocortison GALEN 10mg
Pharmaceutical Form: Tablet
CAS Number: 50-23-7
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Max-Planck-Institut für Psychiatrie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult patients (male and female) between 18 and 75 years 2) 1 -12 month after TBI or SAH before prescreening 3) Cortisol level 100-180 ng/ml after stimulation with ACTH (250 microgramm according to ACTH low-dose short test) 4) Written informed consent by patient or a legally accepted representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation period (during study treatment) 2. Concomitant or previous high-dose therapy with glucocorticoides; previous treatment with glucocorticoides will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 month before study participation. 3. Suspected or known hypersensitivity to hydrocortisone or any of its components 4. Albumine = 2,5 g/dl 5. Suspected or known drug or alcohol abuse 6. Planned treatment for thyroid dysfunction or a planned change in established thyroid treatment 7. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion. 8. Participation in another clinical trial with investigational new drugs 9. Severe medical or psychiatric disease 10. Change of dosage of any other drug which might influence the corticotrope axis or cognitive function (e.g. antidepressive treatment) during the last 3 weeks 11. Oral contraceptives 12. Severe disturbances in articulation, visual faculty or hearing 13. Any elective surgery or medical treatment planned in the observation period 14. Intensive Care treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Changes (?) in score of Alertness test (TAP);Main Objective: To evaluate the interindividual difference (?) of cognitive function in patients with or without hydrocortisone treatment after 7 and 14 days of treatment ;Secondary Objective: To evaluate the intraindividual difference (?) of cognitive function in patients with or without hydrocortisone treatment after 7 and 14 days of treatment | — |
Countries
Germany
Outcome results
None listed