Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- average intraoperative urethral perfusion index
研究概览
简要总结
We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). As pre-planned substudies, we will also assess the agreement between a) urethral perfusion index-derived pulse rate and heart rate measured with an electrocardiogram and b) between the urethral perfusion index and the peripheral perfusion index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 45 years old
- •scheduled for elective major abdominal surgery (involving visceral organs with an expected duration of at least 120 minutes)
- •indication for an arterial catheter
- •indication for an urinary catheter
排除标准
- •Pregnancy
- •Planned surgery: nephrectomy, liver or kidney transplantation surgery
- •Patients who previously had surgery on the urethra or bladder
- •Patients without clinical indication for continuous blood pressure monitoring with an intraarterial catheter
研究组 & 干预措施
Routine hemodynamic management
In patients assigned to routine hemodynamic management, hemodynamic management will be performed according to routine care. The urethral perfusion index measurements will not be visible.
Urethral perfusion index guided hemodynamic monitoring
In patients assigned to urethral perfusion index-guided hemodynamic monitoring, clinicians will be asked to maintaining the intraoperative urethral perfusion index above the postinduction baseline urethral perfusion index during surgery. Interventions to maintain intraoperative urethral perfusion index will be at the clinicians' discretion. All other medical procedures will be performed according to routine care. Clinical judgement will always prevail. Additionally, we will always strive to maintain macrocirculatory variables within predefined safety ranges: Mean arterial pressure: 60 mmHg - 120 mmHg Heart rate: 30 bpm - 120 bpm Cardiac index: at least 2.2 L/min/m2
干预措施: urethal perfusion index monitoring (Device)
结局指标
主要结局
average intraoperative urethral perfusion index
时间窗: Start of surgery until end of surgery
次要结局
- the percentage of surgical time the urethral perfusion index is above the postinduction baseline urethral perfusion index(Start of surgery until end of surgery)
- the lowest intraoperative 5-minute moving average urethral perfusion index(Start of surgery until end of surgery)
- the absolute lowest intraoperative urethral perfusion index(Start of surgery until end of surgery)
- the intraoperative area under the baseline urethral perfusion index(Start of surgery until end of surgery)
- intraoperative area under a urethral perfusion index value 30% below baseline(Start of surgery until end of surgery)
- the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index(Start of surgery until end of surgery)
- cumulative intraoperative duration with a urethral perfusion index below at least 30% lower than baseline(Start of surgery until end of surgery)