Automatic Urine Output Measuring Device Performance Validation and Efficacy.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urine volume measurement.
研究概览
简要总结
To evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit.
详细描述
In order to evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device we will perform a non inferiority of study device in compare with Urinometer (with acceptance of 3% standard deviation), in patients hospitalized in the intensive care unit after cardiac surgery.
Secondary endpoints are to attribute and Identify urine output changes prior to early stage acute renal failure, and identifying urine output changes prior to fluid overload or dehydration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subjects, aged >18 years
- •Patients hospitalized in the intensive care unit requiring an indwelling urinary catheter for urine output monitoring for at least 24 hours.
排除标准
- •Known urological pathology including but not limited to nephrolithiasis, polycystic kidney disease, congenital abnormalities of the kidneys and or urinary tract, history of obstructive uropathy, advanced chronic kidney disease (stage 4) of any cause.
- •Known pregnancy or lactating women.
- •Cognitive and/or psychiatric impairment which may not allow cognitive signing on the informed consent unless patient has a legal representative that was appointed prior to patient enrollment.
研究组 & 干预措施
Post cardiac surgery patients
For all patients, readings of the urine output from both the Serenno system and the collection bag (urinometer) (by camera) will be recorder every 10 minutes, for the duration of 24 hours.
干预措施: Serenno Medical Automatic Urine Output measuring device (Device)
结局指标
主要结局
Urine volume measurement.
时间窗: 24 hours
Automatic device urine output measurement in compare with Urinometer
次要结局
- Acute renal failure detection by urine output measurement and creatinine level in the blood.(24 hours)