Hypotension Prediction Index Guided Prevention of Intradialytic Hypotension During Intermittent Renal Replacement Therapy in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- - Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg)
研究概览
简要总结
This single-center, crossover randomized controlled trial (HyPIR-ICU) investigates whether a Hypotension Prediction Index (HPI)-guided management strategy can reduce intradialytic hypotension (IDH) during prolonged intermittent renal replacement therapy (PIRRT) in critically ill patients. All participants must have an indwelling arterial catheter for continuous hemodynamic monitoring.
详细描述
This study explores whether HPI-guided management during PIRRT can randomization: Block randomization stratified by kidney status (AKI vs. ESKD) and vasopressor use. All parameters are monitored in real-time via the HemosphereⓇ system and reassessed after each intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinicians and participants are aware of the treatment; however, data analysis is blinded and performed independently.
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 >18 years old
- •Diagnosed with acute kidney injury (AKI) or end-stage kidney disease (ESKD)
- •Admitted to medical ICU
- •Scheduled for PIRRT
- •Have an indwelling arterial catheter
排除标准
- •Severe right heart dysfunction, significant valvular disease, arrhythmias, mechanical circulatory support, absence of arterial access, no UF prescription, palliative care, or expected ICU stay <72 hours.
研究组 & 干预措施
HPI first
Arm A: HPI-guided management during first PIRRT → standard care in second session
干预措施: Hypotensive prediction index (Device)
Standard of care first
Arm B: Standard care during first PIRRT → HPI-guided management in second session
干预措施: Standard of care monitoring (Device)
结局指标
主要结局
- Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg)
时间窗: Day 1 and Day 3
Average intensity and duration of time that a patient's mean arterial pressure (MAP) falls below 65 mmHg, which is considered the critical threshold for maintaining adequate organ perfusion.
- Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg)
时间窗: Day 1 and Day 3
Average intensity and duration of time that a patient's mean arterial pressure (MAP) falls below 65 mmHg, which is considered the critical threshold for maintaining adequate organ perfusion.
次要结局
- Intradialytic hypotension frequency by various definitions(Day 1 and Day 3)
- Delivered UF/Prescribed UF(Day 1 and Day 3)
- Incidence of tachycardia or significant arrhythmia(Day 1and Day 3)
- Reaction time to treatment(Day 1 and Day 3)
- Reaction time to treatment(Day 1 and Day 3)
- Intradialytic hypotension frequency by various definitions(Day 1 and Day 3)
- Delivered UF/Prescribed UF(Day 1 and Day 3)
- Incidence of tachycardia or significant arrhythmia(Day 1and Day 3)