FIZE kUO® Real-Time Measurement of Urine Output Response to Fluid Therapy and Diuretics in Cardiovascular Surgery Patients: A Prospective Post-Market Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Urine output response to fluid boluses and diuretics
研究概览
简要总结
This prospective observational study evaluates the real-time urine output response to fluid therapy and diuretics in cardiothoracic intensive care unit (CTICU) patients monitored with the FIZE kUO® device. The study aims to assess how continuous urine output monitoring can inform fluid management and improve patient outcomes post-cardiac surgery.
详细描述
The study involves adult patients undergoing coronary artery bypass graft (CABG) or valve replacement/repair surgeries. Utilizing the FIZE kUO® device, continuous urine output data will be collected to analyze responses to hemodynamic interventions, including fluid boluses and diuretics. Secondary objectives include assessing urine output differences in patients with and without postoperative acute kidney injury (AKI), responses to vasopressors, and capturing real-time urine output data from FIZE kUO® for observational analysis.
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
- •Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU
- •Ability to provide informed consent
排除标准
- •Preoperative dialysis (chronic or acute)
- •Enrollment in other interventional trials assessing urine output or AKI
研究组 & 干预措施
Cardiothoracic ICU Patients
Adult patients (≥18 years old) undergoing coronary artery bypass graft (CABG) and/or valve surgery, admitted postoperatively to the Cardiothoracic Intensive Care Unit (CTICU), and connected to the FIZE kUO® device for real-time urine output monitoring as part of standard care.
干预措施: FIZE kUO® (Device)
结局指标
主要结局
Urine output response to fluid boluses and diuretics
时间窗: 4 hours (2 hours before and 2 hours after intervention)
Change in urine output measured by FIZE kUO® during 2 hours before and after fluid or diuretic administration.
次要结局
- Difference in urine output during surgery between patients with and without AKI(Perioperative/Periprocedural)
- Urine output response to vasopressors(4 hours (2 hours before and 2 hours after intervention))
- Evaluation of FIZE kUO® Urine Output Monitoring Compared to Manual Measurement(Through ICU stay, up to 5 days)