Phase IV Study to Evaluate the Neuropsychological Effects of Hydrocortisone Substitution in Patients With Partial Adrenal Insufficiency After Traumatic Brain Injury or Subarachnoidal Haemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes in score of alertness test (TAP)- interindividual differences
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (male and female) between 18 and 75 years
- •1 -12 month after TBI or SAH before prescreening
- •Cortisol level 100-180 ng/ml after stimulation with ACTH
- •Written informed consent by patient or a legally accepted representative
排除标准
- •Pregnancy and lactation period (during study treatment)
- •Concomitant or previous high-dose therapy with glucocorticoids; previous treatment with glucocorticoids will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 months before study participation
- •Suspected or known hypersensitivity to hydrocortisone or any of its components
- •Albumine less than 2,5 g/dl
- •Suspected or known drug or alcohol abuse
- •Planned treatment for thyroid dysfunction or a planned change in established thyroid treatment
- •Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- •Participation in another clinical trial with investigational new drugs
- •Severe medical or psychiatric disease
- •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
- •Oral contraceptives
- •Severe disturbances in articulation, visual faculty or hearing
- •Any elective surgery or medical treatment planned in the observation period
- •Intensive Care treatment
研究组 & 干预措施
placebo/20 mg hydrocortisone
Order of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone
干预措施: Hydrocortisone (Drug)
placebo/20 mg hydrocortisone
Order of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone
干预措施: Placebo (Drug)
20 mg hydrocortisone/placebo
Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo
干预措施: Hydrocortisone (Drug)
20 mg hydrocortisone/placebo
Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in score of alertness test (TAP)- interindividual differences
时间窗: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)
次要结局
- Changes in score of Alertness Test (TAP) - intraindividual differences(day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo))