NCT03770533已完成不适用
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pilot Study
Brahms AG8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Rate of patients admitted to the hospital
研究概览
简要总结
Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED.
The rationale of this IDEAL study is to provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will be tested in a pilot study first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Consecutive patients presenting to the ED with suspicion of infection
- •Age ≥18 years
- •Written Informed Consent obtained
排除标准
- •Recent major trauma or surgery
- •End stage renal failure requiring dialysis
- •Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure
- •Patients those source of infection always requires hospital admission or never requires hospital admission.
- •Patients who cannot be discharged for other than medical reasons
- •Patient participates in any other interventional clinical trial
- •Patients with active intravenous drug use
- •Pregnant or lactating women
- •Patients who are institutionalized by official or judicial order
- •Dependents of the sponsor, the CRO, the study site or the investigator
结局指标
主要结局
Rate of patients admitted to the hospital
时间窗: 14 days
次要结局
- Number of patients re-presenting to the ED within 28 days(28 days)
- 28 days all-cause hospital re-admission (corrected for mortality)(28 days)
研究者
研究点 (8)
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