Management of Adrenal Emergency in Germany - a Prospective Multicenter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional
研究概览
简要总结
The management of adrenal crisis is often problematic and the time to adequate treatment is frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies requiring parenteral glucocorticoid treatment by a prospective multicenter study in patients with chronic adrenal insufficiency.
详细描述
Despite established hormone replacement therapy, patients with chronic adrenal insufficiency (AI) are at risk of suffering from adrenal crisis (AC). Further data suggests that the management of AC is often problematic and the time to adequate treatment is frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies (AE) requiring parenteral glucocorticoid (GC) treatment by a prospective multicenter study.
Patients with chronic AI receive a questionnaire on the management of emergency situations, which had to be completed and sent back in case of an emergency requiring parenteral GC administration. Furthermore, patients were contacted by phone in case of a missing response every six months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Documented chronic adrenal insufficiency
- •Established corticosteroid replacement therapy
- •Written informed consent
排除标准
- •Age <18 years
结局指标
主要结局
Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional
时间窗: 6-36 months
Evaluation of the median time (in minutes) from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional. The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Median time from the beginning of symptoms to glucocorticoid-injection
时间窗: 6-36 months
Evaluation of the median time (in minutes) from the beginning of symptoms to glucocorticoid-injection during an (adrenal) emergency. The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Duration of hospitalisation (number of days at a hospital)
时间窗: 6-36 months
Evaluation of the duration of hospitalisation (number of days at a hospital) due to an adrenal emergency. The number of days is documented by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Median time from contacting a medical professional to arrival of professional medical help
时间窗: 6-36 months
Evaluation of the median time (in minutes) from contacting a medical professional (by the patient) to arrival of professional medical help during an (adrenal) emergency. The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Number of patients that received an intramuscular glucocorticoid-injection
时间窗: 6-36 months
Evaluation of the number of patients that received an intramuscular glucocorticoid-injection (compared to subcutaneous administration) during an adrenal emergency. Documentation by the patients themselves directly after the adrenal emergency.
次要结局
- Cause of the adrenal emergency(6-36 months)
- Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency(6-36 months)
- Median time from the beginning of symptoms to contacting a medical professional(6-36 months)
- Symptoms of the adrenal emergency(6-36 months)
- Median amount of additionally oral ingested glucocorticoids during the adrenal emergency(6-36 months)