Intradialytic HypotensionHyPIR-ICUNCT07179705
Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients
A study testing Hypotensive prediction index in people with Intradialytic Hypotension and Intensive Care Unit ICU, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension, Intensive Care Unit ICU, Hemodialysis Patients
- What is being tested?
- Hypotensive prediction index
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteThailand
- Study dates
- 10 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Division of Nephrology, Faculty of Medicine, Chulalongkorn University
Bangkok
Nattapakorn Mai-on, 66970051116, nattapakorn.m@gmail.com
About this study
Official title: Hypotension Prediction Index Guided Prevention of Intradialytic Hypotension During Intermittent Renal Replacement Therapy in Intensive Care Units
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.
Read the 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.
- Being tested
- Hypotensive prediction index, Standard of care monitoring
- Keywords
- Hypotension Prediction Index (HPI), Prolonged intermittent renal replacement therapy (PIRRT), Slow-low efficiency dialysis, Intradialytic hypotension, Hemodynamic monitoring, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotensive prediction indexDevice
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 monitoringDevice
Standard of Care
- Monitoring via conventional invasive BP and clinical judgment
- Use of physical exam, CVP, PPV, and response-based decisions (fluid bolus, vasopressors)
| Study group | Role | What they receive |
|---|---|---|
| HPI first | Experimental | Arm A: HPI-guided management during first PIRRT → standard care in second session Receives: Device: Hypotensive prediction index |
| Standard of care first | Experimental | Arm B: Standard care during first PIRRT → HPI-guided management in second session Receives: Device: Standard of care monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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.
Measured: Day 1 and Day 3
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 1 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start10 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179705
- Sponsor's protocol ID
- 0204/68
- Acronym
- HyPIR-ICU
- Status last verified
- May 2026
- First submitted
- 21 Jul 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotension Prediction Index Guided Prevention of Intradialytic Hypotension During Intermittent Renal Replacement Therapy in Intensive Care Units
- ClinicalTrials.gov ID
- NCT07179705
- Acronym / sponsor ID
- HyPIR-ICU / 0204/68
- Keywords
- Hypotension Prediction Index (HPI), Prolonged intermittent renal replacement therapy (PIRRT), Slow-low efficiency dialysis, Intradialytic hypotension, Hemodynamic monitoring, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| HPI first | Experimental | Device: Hypotensive prediction indexArm A: HPI-guided management during first PIRRT → standard care in second session |
| Standard of care first | Experimental | Device: Standard of care monitoringArm B: Standard care during first PIRRT → HPI-guided management in second session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotensive prediction indexThe 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 | HPI first |
| Standard of care monitoringStandard of Care * Monitoring via conventional invasive BP and clinical judgment * Use of physical exam, CVP, PPV, and response-based decisions (fluid bolus, vasopressors) | Device | Standard of care first |
Primary outcome
- Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg)
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotensive prediction index in people with Intradialytic Hypotension and Intensive Care Unit ICU, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nattapakorn Mai-on (66970051116, nattapakorn.m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Time-weighted average mean arterial pressure <65 mmHg (TWA-MAP<65 mmHg) (time frame: Day 1 and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.