An interventional study of Hypotensive prediction index and Standard of care monitoring in Intradialytic Hypotension, Intensive Care Unit ICU and Hemodialysis Patients, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Diagnostic
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.
Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm A: HPI-guided management during first PIRRT → standard care in second session
Device: Hypotensive prediction index
Arm B: Standard care during first PIRRT → HPI-guided management in second session
Device: Standard of care monitoring
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.
Standard of Care * Monitoring via conventional invasive BP and clinical judgment * Use of physical exam, CVP, PPV, and response-based decisions (fluid bolus, vasopressors)
- 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.
Time frame: Day 1 and Day 3
Intradialytic hypotension frequency by various definitions
* Nadir90: Minimal intra-hemodialytic SBP\<90 mmHg * Fall20: Pre-hemodialysis SBP - Minimal intra-hemodialytic SBP \>20 mmHg * Fall20Nadir90: Meet criteria for Nadir 90 and Fall20 * HEMO: Fall in SBP resulting in intervention of UF reduction, blood flow reduction, or intervention administration
Time frame: Day 1 and Day 3
Delivered UF/Prescribed UF
* Prescribed UF (Ultrafiltration): The amount of fluid (in milliliters or liters) * Delivered UF: The actual amount of fluid successfully removed during the session. * This ratio reflects the efficacy of fluid removal.
Time frame: 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
Time frame: 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
Time frame: Day 1 and Day 3
Plan to share: No
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Chulalongkorn University