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NCT Number: NCT07179705

Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients

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.

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Key information

Conditions

Intradialytic Hypotension Hemodialysis Patients Intensive Care Unit ICU

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Nephrology, Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

Location status: Recruiting

Location contact

Nattapakorn Mai-on

CONTACT

[email protected]

66970051116

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard of care monitoring

Device

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 outcomes

  1. - 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.

Secondary outcomes

  1. Intradialytic hypotension frequency by various definitions

    Time frame: 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

  2. Delivered UF/Prescribed UF

    Time frame: 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.

  3. Incidence of tachycardia or significant arrhythmia

    Time frame: 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

  4. Reaction time to treatment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nattapakorn Mai-on

CONTACT

[email protected]

66970051116

Nuttha Lumlertgul

CONTACT

[email protected]

66855788949

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Hypotension Prediction Index Guided Prevention of Intradialytic Hypotension During Intermittent Renal Replacement Therapy in Intensive Care Units

Acronym: HyPIR-ICU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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