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

ConditionsIntradialytic HypotensionIntensive Care Unit ICUHemodialysis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults >18 years old

Diagnosed with acute kidney injury (AKI) or end-stage kidney disease (ESKD)

Admitted to medical ICU

Scheduled for PIRRT

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • 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)

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: HPI firstExperimental treatment 1 intervention
Group B: Standard of care firstExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

- 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

Secondary outcomes

1

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
2

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
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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov
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