Hemodialysis Patients, Intensive Care Unit ICU, Intradialytic Hypotension
Conditions
Keywords
Hypotension Prediction Index (HPI), Prolonged intermittent renal replacement therapy (PIRRT), Slow-low efficiency dialysis, Intradialytic hypotension, Hemodynamic monitoring, Intensive Care Unit
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHypotensive prediction index
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)
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinicians and participants are aware of the treatment; however, data analysis is blinded and performed independently.
Intervention model description
Study Design * Crossover design: Each participant receives both interventions (HPI-guided and standard care) during two dialysis sessions, with a 1-2 day washout between sessions. * Randomization: Block randomization stratified by kidney status (AKI vs. ESKD) and vasopressor use. * Open-label: Clinicians and participants are aware of the treatment; however, data analysis is blinded and performed independently. 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| - Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intradialytic hypotension frequency by various definitions | Day 1 and Day 3 | * 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 |
| Delivered UF/Prescribed UF | Day 1 and Day 3 | * 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. |
| Incidence of tachycardia or significant arrhythmia | Day 1and Day 3 | Incidence of tachycardia or significant arrhythmia: defined by HR\>130 bpm or HR increase \>20% from pre-hemodialysis baseline for \>15 min |
| Reaction time to treatment | Day 1 and Day 3 | 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 |
Countries
Thailand
Contacts
CONTACTNattapakorn Mai-on
CONTACTNuttha Lumlertgul
Outcome results
None listed