Delirium Incidence and Indwelling Urinary CathEterization After Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients.
详细描述
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients. With a prospective randomized-controlled interventional study design it aims to provide reliable evidence to effectively reduce delirium as well as secondary complications after IUC in critically ill patients. Until now, male, severely affected acute stroke patients regularly receive IUC for recanalization therapy or to balance fluid intake. Complications might be urinary infections, agitation and accidental removal by the patient himself with urinary bleeding.
We ought to investigate if early removal of the IUC after recanalization therapy and replacement with either a condom catheter or a diaper might reduce complications after catheterization and hereby reduce delirium.
As a secondary outcome we would like to explore other options besides indwelling urinary catheterization for balancing the fluid in- and output.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
outcome assessor is masked for intervention
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Male gender
- •Age ≥ 70 years
- •Treated with recanalization therapy and therefore receiving an IUC
- •Patient is able to provide written informed consent. If patient is aphasic and not in a position to provide written informed consent after the stroke, a relative or a legal guardian can provide information of the presumed will of the patient.
- •Inclusion of this patient is possible if the patient will give basic informed consent as soon as he is able to and after a maximum of seven days after enrollment.
- •As delirium is associated with stroke severity it is necessary to include these patients, otherwise the incidence of delirium will be too low.
排除标准
- •Delirium at admission
- •Need for mechanical ventilation > 48h
- •Presence of an IUC before admission
研究组 & 干预措施
usual care (IUC)
condom catheter
干预措施: condom catheter (Device)
结局指标
主要结局
Delirium
时间窗: 10 days after admission
The primary outcome will be the development of delirium within 10 days after admission. Secondary outcomes will be * Length of stay on NICU / stroke unit * Development of UTI * Development of neurological bladder dysfunction * Pleura effusions and/or ankle edema
次要结局
未报告次要终点