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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPI first | Experimental | Arm A: HPI-guided management during first PIRRT → standard care in second session |
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| Standard of care first | Experimental | Arm B: Standard care during first PIRRT → HPI-guided management in second session |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypotensive prediction index | Device | The HPI, developed by Edwards Lifesciences and integrated into the HemosphereⓇ hemodynamic monitoring system, is an algorithm-based tool that predicts hypotensive events before they occur, allowing earlier intervention. While this tool has shown benefit in surgical and post-operative settings, it has not been tested in ICU patients undergoing dialysis. |
| Measure | Description | Time Frame |
|---|---|---|
| - Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg) | 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. | Day 1 and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Intradialytic hypotension frequency by various definitions |
| Day 1 and Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nattapakorn Mai-on | Contact | 66970051116 | nattapakorn.m@gmail.com | |
| Nuttha Lumlertgul | Contact | 66855788949 | nlumlertgul@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology, Faculty of Medicine, Chulalongkorn University | Recruiting | Bangkok | Thailand |
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Study Design
Intervention Arm A: HPI-guided management during first PIRRT → standard care in second session Arm B: Standard care during first PIRRT → HPI-guided management in second session
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Clinicians and participants are aware of the treatment; however, data analysis is blinded and performed independently.
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| Standard of care monitoring | Device | Standard of Care
|
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| Delivered UF/Prescribed UF |
| Day 1 and Day 3 |
| Incidence of tachycardia or significant arrhythmia | Incidence of tachycardia or significant arrhythmia: defined by HR>130 bpm or HR increase >20% from pre-hemodialysis baseline for >15 min | Day 1and Day 3 |
| Reaction time to treatment | Reaction time to treatment refers to the interval between the detection of a hypotensive event (or risk of it) and the initiation of appropriate clinical intervention | Day 1 and Day 3 |