Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypotensive prediction index, Standard of care monitoring.
- Who it may be relevant to
- Registry conditions: Intradialytic Hypotension, Intensive Care Unit ICU, Hemodialysis Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypotension Prediction Index Guided Prevention of Intradialytic Hypotension During Intermittent Renal Replacement Therapy in Intensive Care Units
Overview
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
- Device Hypotensive 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. - Device Standard of care monitoring
Standard of Care * Monitoring via conventional invasive BP and clinical judgment * Use of physical exam, CVP, PPV, and response-based decisions (fluid bolus, vasopressors)
Primary outcome measures
- - Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg) [Time frame: Day 1 and Day 3]
Secondary outcome measures (4)
- Intradialytic hypotension frequency by various definitions [Time frame: Day 1 and Day 3]
- Delivered UF/Prescribed UF [Time frame: Day 1 and Day 3]
- Incidence of tachycardia or significant arrhythmia [Time frame: Day 1and Day 3]
- Reaction time to treatment [Time frame: Day 1 and Day 3]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Thailand · 1 center
- Division of Nephrology, Faculty of Medicine, Chulalongkorn University — Bangkok
Identifiers
NCT: NCT07179705 · 0204/68